Allergic Disorders Archives - MPR Thu, 18 Apr 2024 21:31:07 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.3 https://www.empr.com/wp-content/uploads/sites/7/2023/03/cropped-empr-32x32.jpg Allergic Disorders Archives - MPR 32 32 ACTHAR GEL https://www.empr.com/drug/acthar-gel/ Mon, 06 Feb 2023 21:00:52 +0000 https://www.empr.com/drug/h-p-acthar-gel/ ADRENACLICK https://www.empr.com/drug/adrenaclick/ Thu, 22 Jul 2021 11:29:54 +0000 https://www.empr.com/drug/adrenaclick/ ADRENALIN https://www.empr.com/drug/adrenalin/ Thu, 22 Jul 2021 10:11:22 +0000 https://www.empr.com/drug/adrenalin/ Adverse Pregnancy Outcomes Common Among Patients With Autoimmune Skin Diseases https://www.empr.com/reports/adverse-pregnancy-outcomes-common-in-autoimmune-skin-diseases/ Mon, 13 Nov 2023 12:23:13 +0000 https://www.rheumatologyadvisor.com/?post_type=report&p=121938 Individuals with autoimmune skin diseases (ASDs) are at greater risk for adverse pregnancy outcomes (APOs) compared against healthy patients, with frequency also increased among those with systemic lupus erythematosus (SLE), according to study results presented at the American College of Rheumatology (ACR) 2023 Annual Meeting, held from November 10 to 15, in San Diego, California.

Increased rates of APOs are associated with rheumatic diseases like SLE, rheumatoid arthritis (RA), and dermatomyositis, but little is known about pregnancy outcomes among patients with ASDs. Therefore, researchers conducted a case-control study to assess the frequency of APOs among women with ASDs.

Data were taken from the TriNetX United States Collaborative Network database and included patients aged between 15 to 44 years who were pregnant, from January 1, 2016, to December 31, 2021.

Patients with ASDs were propensity score matched 1:1 with members of two control groups for comparison: 1) healthy patients without ASDs, RA, or SLE and 2) individuals with RA or SLE who were considered members of the disease-control group.

In contrast, those with SLE have a greater frequency of APOs indicating that all these groups may benefit from multidisciplinary care with maternal-fetal medicine specialists.

The study included 3654 patients with ASDs and 3654 members of the control groups (2147 patients with SLE and 889 with RA).

Patients with ASDs were at greater risk of experiencing spontaneous abortion and preeclampsia/eclampsia compared with members of the healthy control group.

Specifically, the risk for spontaneous abortion was 1.5 times higher among patients with ASDs than in the healthy control group (P <.001), while the risk for preeclampsia/eclampsia was 1.2 times higher among patients with ASDs compared with the healthy control group (P =.04).

Compared against women with SLE, women with ASDs were less likely to experience preeclampsia/eclampsia, have a preterm birth, experience preterm premature rupture of membranes (PPROM), or have a fetus with intrauterine growth restriction (IUGR).

Specifically, the risk for preeclampsia/eclampsia was 0.7 times lower (P =.001), the risk of delivering preterm was 0.5 times lower (P <.001), the risk for PPROM was 0.6 times lower (P =.004), and the risk of having a fetus with IUGR was 0.6 times lower (P <.001) among women with ASDs vs women with SLE.

Women with ASDs were more 1.2 times more likely to experience a spontaneous abortion than women with SLE (P =.003). Patients with ASDs and RA were at similar risk for APOs.

The study authors concluded, “These results suggest that patients with ASDs have increased rates of adverse pregnancy outcomes compared to healthy controls and are similar in risk to RA. In contrast, those with SLE have a greater frequency of APOs indicating that all these groups may benefit from multidisciplinary care with maternal-fetal medicine specialists.”

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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ALAVERT ODT https://www.empr.com/drug/alavert-odt/ Thu, 22 Jul 2021 10:11:24 +0000 https://www.empr.com/drug/alavert-odt/ ALLEGRA https://www.empr.com/drug/allegra/ Thu, 23 Sep 2021 19:16:38 +0000 https://www.empr.com/drug/allegra/ ALLEGRAFexofenadine HCl 60mg tabs; 180mg tabs, gelcaps.]]> ALLEGRA]]> Allergic Conjunctivitis Treatments https://www.empr.com/charts/allergic-conjunctivitis-treatments/ Tue, 10 Mar 2015 18:00:00 +0000 https://www.empr.com/uncategorized/allergic-conjunctivitis-treatments/ #articleColumn table.wkm ul li{padding: 0 0 10px 1em;}#articleColumn table.wkm p{ margin-bottom: 0;line-height: 120%;}.wkm-div {overflow: auto; }.wkm-SeeOnPhone { display: none; }thead.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif !important; font-weight: bold !important; font-size: 12px !important; font-style: normal; background-color: #D3DFE5; margin-top: 0; margin-bottom: 0; vertical-align: bottom; }tbody.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; 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ALLERGIC CONJUNCTIVITIS TREATMENTS
Generic Brand Strength Size Dose
ANTIHISTAMINE
cetirizine Zerviate Rx 0.24% 5mL, 7.5mL <2yrs: Not established.
≥2yrs:
1 drop in each affected eye twice daily (~8hrs apart)
CORTICOSTEROID
loteprednol etabonate Alrex Rx 0.2% 5mL, 10mL Children: Not recommended.
Adults: 1 drop in affected eye(s) 4 times daily
MAST CELL STABILIZER
cromolyn sodium Rx 4% 10mL <4yrs: Not established.
≥4yrs: 1–2 drops 4–6 times daily
lodoxamide tromethamine Alomide Rx 0.1% 10mL <2yrs: Not recommended.
≥2yrs: 1–2 drops 4 times daily for up to 3mos
nedocromil sodium Alocril Rx 2% 5mL <3yrs: Not recommended.
≥3yrs: 1–2 drops in each eye twice daily
MAST CELL STABILIZER/ANTIHISTAMINE
alcaftadine Lastacaft Rx 0.25% 3mL <2yrs: Not recommended.
≥2yrs: 1 drop in each eye once daily
azelastine HCl Rx 0.05% 6mL <3yrs: Not recommended.
≥3yrs: 1 drop in affected eye(s) twice daily
bepotastine besilate Bepreve Rx 1.5% 5mL, 10mL <2yrs: Not recommended.
≥2yrs: 1 drop in affected eye(s) twice daily
epinastine HCl Elestat Rx 0.05% 5mL <2yrs: Not established.
≥2yrs: 1 drop in each eye twice daily
ketotifen fumarate Alaway OTC 0.025% 10mL <3yrs: Not recommended.
≥3yrs: 1 drop in affected eye(s) every 8–12hrs; max 2 doses/day
Zaditor OTC 0.025% 5mL
olopatadine HCl Rx 0.1% 5mL <3yrs: Not recommended.
≥3yrs: 1 drop in affected eye(s) twice daily, 6–8hrs apart
Pataday Once Daily Relief OTC 0.2% 2.5mL <2yrs: Consult physician.
≥2yrs:
1 drop in affected eye(s) once daily
Pataday Once Daily Relief Extra Strength OTC 0.7% 2.5mL <2yrs: Consult physician.
≥2yrs:
1 drop in affected eye(s) once daily; max once per day
Pataday Twice Daily Relief OTC 0.1% 5mL <2yrs: Consult physician.
≥2yrs:
1 drop in affected eye(s) twice daily, 6–8hrs apart
NSAID
ketorolac tromethamine Acular Rx 0.5% 5mL <2yrs: Not established.
≥2yrs: 1 drop 4 times daily
VASOCONSTRICTOR + ANTIHISTAMINE
naphazoline HCl + pheniramine maleate Naphcon-A OTC 0.025% + 0.3% 15mL <6yrs: Not recommended.
≥6yrs: 1–2 drops up to 4 times daily
Visine Allergy Eye Relief 15mL
VASOCONSTRICTOR + ASTRINGENT
tetrahydrozoline HCl + zinc sulfate Visine-AC OTC 0.05% + 0.25% 15mL, 30mL <6yrs: Not recommended.
≥6yrs: 1–2 drops up to 4 times daily
NOTES

Do not wear contact lenses during treatment. To prevent contamination, the dropper tip should not touch the eyelids or surrounding areas. Keep the bottle tightly closed when not in use.

All products mentioned contain benzalkonium chloride. May be absorbed by soft contact lenses. Avoid wearing lenses with signs and symptoms of allergic conjunctivitis, especially if eye is red. Contact lenses may be worn but should be removed prior to instillation and reinserted 10min after dosing if eye is not red.

Not an inclusive list of medications and/or official indications. Please see drug monograph at www.eMPR.com and/or contact company for full drug labeling.

(Rev. 9/2022)

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Anaphylaxis Management https://www.empr.com/charts/anaphylaxis-management/ Tue, 14 Aug 2012 20:01:00 +0000 https://www.empr.com/uncategorized/anaphylaxis-management/ #articleColumn table.wkm ul li{padding: 0 0 10px 1em;}#articleColumn table.wkm p{ margin-bottom: 0;line-height: 120%;}.wkm-div {overflow: auto; }.wkm-SeeOnPhone { display: none; }thead.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif !important; font-weight: bold !important; font-size: 12px !important; font-style: normal; background-color: #D3DFE5; margin-top: 0; margin-bottom: 0; vertical-align: bottom; }tbody.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; font-size: 12px!important; font-weight: normal!important; font-style: normal!important; line-height: 120% !important; text-align: left!important; background-color: #F4F7F8!important; margin-top: 0!important; margin-bottom: 0!important; vertical-align: top!important; }tfoot.wkm {font-family: "Frutiger", "Verdana", "Helvetica", "Arial", sans-serif; 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Anaphylaxis Management

ANAPHYLAXIS MANAGEMENT
OUTPATIENT SETTING
First-line Treatment

• EPINEPHRINE, IM; auto-injector or 1:1000 solution

º Weight 10–25kg: 0.15mg epinephrine autoinjector, IM (anterior-lateral thigh)

º Weight>25kg: 0.3mg epinephrine autoinjector, IM (anterior-lateral thigh)

º Epinephrine (1:1000 solution) IM, 0.01mg/kg per dose; max 0.5mg per dose (anterior-lateral thigh)

º May need to repeat epinephrine dose every 5–15min

Adjunctive Treatment

• Bronchodilator (β2-agonist): ALBUTEROL

º MDI (Children: 4–8 puffs; Adults: 8 puffs) or

º Nebulized solution (Children: 1.5mL; Adults: 3mL) every 20min or continuously as needed

• H1 antihistamine: DIPHENHYDRAMINE

º 1–2mg/kg per dose; max 50mg IV or PO (oral liquid is more readily absorbed than tablets)

º Alternative dosing may be used with a less-sedating second generation antihistamine

• Supplemental oxygen therapy

• IV fluids in large volumes if patient presents with orthostasis, hypotension, or incomplete response to IM epinephrine

• Place the patient in recumbent position if tolerated, with the lower extremities elevated

HOSPITAL-BASED SETTING
First-line Treatment

• EPINEPHRINE IM (as above, outpatient setting), consider continuous epinephrine infusion for persistent hypotension (ideally with continuous non-invasive monitoring of blood pressure and heart rate); alternatives are endotracheal or intra-osseous epinephrine

Adjunctive Treatment

• Bronchodilator (β2-agonist): ALBUTEROL

º MDI (Children: 4–8 puffs; Adults: 8 puffs) or

º Nebulized solution (Children: 1.5mL; Adults: 3mL) every 20min or continuously as needed

• H1 antihistamine: DIPHENHYDRAMINE

º 1–2mg/kg per dose; max 50mg IV or PO (oral liquid is more readily absorbed than tablets)

º Alternative dosing may be used with a less-sedating second generation antihistamine

• H2 antihistamine: RANITIDINE

º 1–2mg/kg per dose; max 75–150mg PO and IV

• Corticosteroids

º PREDNISONE: 1mg/kg; max 60–80mg PO or

º METHYLPREDNISOLONE: 1mg/kg; max 60–80mg IV

• Vasopressors (other than epinephrine) for refractory hypotension, titrate to effect

• GLUCAGON for refractory hypotension, titrate to effect

º Children: 20–30mcg/kg

º Adults: 1–5mg

º May repeat dose or followed by infusion of 5–15mcg/min

• ATROPINE for bradycardia, titrate to effect

• Supplemental oxygen therapy

• IV fluids in large volumes if patient presents with orthostasis, hypotension, or incomplete response to IM epinephrine

• Place the patient in recumbent position if tolerated, with the lower extremities elevated

THERAPY AT DISCHARGE
First-line Treatment

• EPINEPHRINE, auto-injector prescription (2 doses) and instructions

• Education on avoidance of allergen

• Follow-up with primary care physician

• Consider referral to an allergist

Adjunctive Treatment

• H1 antihistamine: DIPHENHYDRAMINE every 6hrs for 2–3 days; alternative dosing with a non-sedating second generation antihistamine

• H2 antihistamine: RANITIDINE twice daily for 2–3 days

• Corticosteroid: PREDNISONE daily for 2–3 days

NOTES

These treatments often occur concomitantly, and are not meant to be sequential, with the exception of epinephrine as first-line treatment.

REFERENCES

Adapted from Boyce JA, Assa’ad A, Burks AW, et al. Guidelines for the Diagnosis and Management of Food Allergy in the United States: Summary of the NIAID-Sponsored Expert Panel Report. J Allergy Clin Immunol 2010; 126(6):1105–18. http://www.niaid.nih.gov/topics/foodAllergy/clinical/Documents/
FAGuidelinesExecSummary.pdf

(Rev. 7/2023)

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Antihistamine Nasal Spray Astepro Allergy Now Available OTC https://www.empr.com/home/news/antihistamine-nasal-spray-astepro-allergy-now-available-otc/ Tue, 12 Jul 2022 20:05:00 +0000 https://www.empr.com/?p=183010 Girl blowing nose, allergic rhinitis, nasal congestionAstepro Allergy is the first OTC steroid-free antihistamine nasal spray for indoor and outdoor allergies.]]> Girl blowing nose, allergic rhinitis, nasal congestion

Astepro® Allergy (azelastine HCI 0.15%) is now available over-the-counter (OTC) for the temporary relief of nasal congestion, runny nose, sneezing and itchy nose due to hay fever or other upper respiratory allergies in adults and children 6 years of age and older.

Astepro Allergy is the first OTC steroid-free antihistamine nasal spray for indoor and outdoor allergies. Each nasal spray delivers 0.137mL solution containing 205.5mcg of azelastine hydrochloride, an H1-receptor antagonist. The product may be administered once daily or twice daily and provides relief for up to 24 hours.

Due to the risk of somnolence associated with the use of azelastine, the label for Astepro Allergy warns consumers to avoid alcoholic drinks and to be cautious when driving a motor vehicle or operating machinery. Additionally, consumers should avoid sedatives or tranquilizers when using the product.

Astepro Allergy is supplied in 22-, 60-, 120-, 200-, and 240 (2×120 spray)-metered spray bottles. 

Azelastine HCl nasal spray 0.1% (137mcg/spray) will remain prescription based for seasonal allergic rhinitis and vasomotor rhinitis.

References

  1. Astepro® Allergy, first and only steroid-free antihistamine nasal spray now available over-the-counter. News release. Bayer. Accessed July 12, 2022. https://www.businesswire.com/news/home/20220712005124/en/Astepro%C2%AE-Allergy-First-and-Only-Steroid-Free-Antihistamine-Nasal-Spray-Now-Available-Over-the-Counter
  2. Products: Astepro Allergy. Astepro Allergy. Accessed July 12, 2022. https://www.asteproallergy.com/products/astepro-allergy-nasal-spray

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Asthma Drug Fluticasone Fails as Potential COVID-19 Treatment https://www.empr.com/home/news/asthma-drug-fluticasone-fails-as-potential-covid-19-treatment/ Fri, 15 Jul 2022 13:11:00 +0000 https://www.empr.com/?p=183145 coronavirus disease 2019 covid lungs illustration

Finding from a nationwide study of 5,000 participants that continues to evaluate existing drugs to treat mild-to-moderate COVID-19

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coronavirus disease 2019 covid lungs illustration

HealthDay News — The asthma drug fluticasone furoate is yet another medication that does not work for mild-to-moderate COVID-19, a new study finds. The study was published online July 13 in medRxiv, which publishes studies before they have been peer-reviewed.

“There was no evidence of improvement in time to recovery or reduction in hospitalizations in participants who took fluticasone furoate versus those who took a placebo,” lead researcher Adrian Hernandez, MD, executive director of the Duke Clinical Research Institute in Durham, North Carolina, said in a Duke news release.

The finding comes from a nationwide study of nearly 5000 participants that continues to evaluate the potential benefit of existing drugs to treat mild-to-moderate COVID-19. Fluticasone furoate is one of three US Food and Drug Administration-approved repurposed medications currently being tested against COVID-19.

Fluticasone furoate is an inhaled corticosteroid used to treat asthma, but it is not approved to treat COVID-19. This drug was tested because corticosteroids had seemed potentially beneficial for treating COVID-19 among nonhospitalized patients. Based on the findings, fluticasone furoate should not be used to treat COVID-19, the researchers stressed.

Abstract/Full Text (subscription or payment may be required)

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Asthma Exacerbations and Systemic Corticosteroid Use Reduced With Dupilumab https://www.empr.com/home/mpr-first-report/acaai-2022/asthma-exacerbations-and-systemic-corticosteroid-use-reduced-with-dupilumab/ Tue, 15 Nov 2022 14:48:00 +0000 https://www.empr.com/?p=188215 Asthma diagram, lungsThe primary outcome was to compare dupilumab, benralizumab, and mepolizumab in patients with at least 2 pre-index exacerbations.]]> Asthma diagram, lungs

Asthma exacerbations and systemic corticosteroid (SCS) prescriptions are significantly reduced in patients who receive dupilumab vs patients who receive omalizumab, benralizumab, or mepolizumab, according to study findings presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, held from November 10 to 14, 2022, in Louisville, Kentucky.

Researchers conducted an exploratory review and analysis of US electronic medical record (EMR) data that included patients (N=5361) aged at least 12 years with an asthma diagnosis. Participants initiated dupilumab (n=2138), omalizumab (n=1313), benralizumab (n=918), or mepolizumab (n=992) between November 2018 and September 2020 and had 12 months pre- and post-index data. The primary outcome was to compare dupilumab, benralizumab, and mepolizumab in patients with at least 2 pre-index exacerbations.

Each of the comparison cohorts had inverse probability treatment weighting applied. Negative binomial regression models were used to analyze asthma exacerbations and SCS prescription orders. The researchers performed pairwise comparisons between dupilumab and omalizumab, benralizumab, or mepolizumab. Potential residual confounding in all models was adjusted for with doubly robust estimation.

At least 2 exacerbations in dupilumab (825), benralizumab (461), and mepolizumab (451) were observed among all patients during the pre-index period. The number of patients receiving omalizumab with at least 2 exacerbations pre-index was not mentioned. Dupilumab significantly reduced exacerbations in the post-index period (P <.0001) by 44% vs omalizumab, 24% vs benralizumab, and 28% vs mepolizumab.

There was a significant reduction in SCS prescriptions in the post-index period with dupilumab treatment by 28% vs omalizumab, 16% vs benralizumab, and 25% vs mepolizumab. Limitations of the study include the use of EMR data.

The study authors conclude, “This exploratory EMR study demonstrated a significantly greater reduction in asthma exacerbations and SCS prescription in patients prescribed with dupilumab vs those on omalizumab, benralizumab, or mepolizumab.”

Reference

Bleecker E, Blaiss M, Jacob-Nara J, et al. Real-world effectiveness of dupilumab and other biologics on asthma exacerbations and steroid prescriptions: US-ADVANTAGE StudyAnn Allergy Asthma Immunol. 2022;125(5):S38. doi:10.1016/j.anai.2022.08.611

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Asthma, Atopy Risks Up in Offspring Born Via Infertility Treatment https://www.empr.com/home/news/asthma-atopy-risks-up-in-offspring-born-via-infertility-treatment/ Wed, 27 Apr 2022 13:00:00 +0000 https://www.empr.com/?p=179935

Long-term follow-up of children shows increased asthma/allergy risk, independent of parental history of asthma and atopy

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HealthDay News — Children conceived with infertility treatment have an elevated risk for asthma and atopic conditions in early and middle childhood, according to a study published online April 21 in Human Reproduction.

Kristen J. Polinski, PhD, from the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, Maryland, and colleagues analyzed singletons and multiples born between 2008 and 2010 (5034 mothers and 6171 children) with follow-up until 2019 (2056 children in the middle childhood follow-up).

The researchers found that children conceived with any infertility treatment had an increased risk for persistent wheeze by age 3 years (relative risk [RR], 1.66; 95% CI, 1.17 to 2.33) when adjusting for parental atopy and other risk factors, compared with children conceived without treatment. Children conceived with treatment were more likely to have current asthma between ages 7 and 9 years (RR, 1.30; 95% CI, 0.98 to 1.71), as well as eczema (RR, 1.77; 95% CI, 1.25 to 2.49) and prescription of allergy-related medications (RR, 1.45; 95% CI, 1.06 to 1.99). When examining associations by infertility treatment type, effect sizes were similar.

“Our findings of similar effect sizes by infertility treatment type suggest either shared biological process of inducing ovulation leading to fetal exposure to supraphysiological hormone levels or underlying parental subfertility may contribute to risk,” the authors write.

Abstract/Full Text (subscription or payment may be required)

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August 2023 Recap: Drug Pipeline Updates https://www.empr.com/home/news/drugs-in-the-pipeline/august-2023-recap-drug-pipeline-updates/ Fri, 15 Sep 2023 14:00:00 +0000 https://www.empr.com/?p=206601 The table below is a review of notable updates that occurred in August 2023 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

Drug Pharmacologic Class Proposed Indication Status
Allergic Disorders
Remibrutinib (Novartis) Bruton tyrosine kinase inhibitor Treatment of chronic spontaneous urticaria in patients inadequately controlled by second generation H1 antihistamines. Phase 3 results
Endocrine Disorders
Dasiglucagon (Zealand Pharma) Glucagon analog Treatment of hypoglycemia in pediatric patients 7 days of age and older with congenital hyperinsulinism for up to 3 weeks of dosing. Priority Review
Gastrohepatic Disorders
Risankizumab (AbbVie) Interleukin-23 inhibitor Treatment of adults with moderately to severely active ulcerative colitis. BLA submitted
Immunization
CHIKV VLP (Bavarian Nordic) Adjuvanted virus-like particle (VLP)-based vaccine. Chikungunya virus vaccine candidate. Phase 3 results
VLA1553 (Valneva) Live-attenuated, single-dose vaccine. Chikungunya virus vaccine candidate. PDUFA date extended
Infectious Disease
Cefepime-taniborbactam (Venatorx Pharmaceuticals) Beta-lactam/beta-lactamase inhibitor antibiotic Treatment of adults with complicated urinary tract infections, including pyelonephritis. Priority Review
Ceftobiprole medocaril (Basilea) Cephalosporin antibiotic Treatment of Staphylococcus aureus bacteremia, including right-sided infective endocarditis, acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. NDA submitted
Isavuconazonium sulfate (Astellas Pharma) Azole antifungal Treatment of invasive aspergillosis or invasive mucormycosis in pediatric patients 1 to 17 years of age. Supplemental NDA accepted for review
Metabolic Disorders
TYRA-300 (Tyra Biosciences) FGFR3-selective inhibitor Treatment of achondroplasia. Orphan Drug status
Neurologic Disorders
AOC 1044 (Avidity Biosciences) Antibody oligonucleotide conjugate Treatment of Duchenne muscular dystrophy in patients with mutations amenable to exon 44 skipping. Orphan Drug status
Long-acting glatiramer acetate (Viatris and Mapi Pharma) Immunomodulator Treatment of relapsing forms of multiple sclerosis. NDA accepted for review
Pamrevlumab (FibroGen) Fully human antibody that works by inhibiting the activity of connective tissue growth factor Treatment of ambulatory patients with Duchenne muscular dystrophy who are taking background corticosteroids. Phase 3 results
TSHA-102 (Taysha Gene Therapy) Adeno-associated virus 9 gene transfer therapy Treatment of Rett syndrome. Fast Track designation
Obstetrics and Gynecology
CBP-4888 (Comanche Biopharma) Fixed-dose combo of 2 lipid-conjugated small interfering ribonucleic acid duplex oligonucleotides Treatment of preeclampsia. Fast Track designation
Oncology
Avasopasem manganese (Galera Therapeutics) Selective dismutase mimetic Radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard of care treatment. Complete Response Letter issued
Bexmarilimab (Faron) Monoclonal antibody designed to target the Clever-1 immunosuppressive receptor on macrophages Treatment of acute myeloid leukemia. Orphan Drug designation
Enzalutamide (Astellas Pharma) Androgen receptor inhibitor Treatment of patients with non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence. Priority Review
Erdafitinib (Balversa) Kinase inhibitor Treatment of patients with locally advanced or metastatic urothelial carcinoma, that has susceptible fibroblast growth factor receptor 3 genetic alterations, and progressed during or following at least 1 line of a programmed death receptor-1 or programmed death-ligand 1 inhibitor, in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy. Supplemental NDA submitted
Imetelstat (Geron) Telomerase inhibitor Treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes. NDA accepted for review
Ivosidenib (Servier) Isocitrate dehydrogenase 1 inhibitor Treatment of patients with isocitrate dehydrogenase 1-mutated relapsed or refractory myelodysplastic syndromes. Priority Review
Ophthalmic Disorders
Bevacizumab (Outlook Therapies) Vascular endothelial growth factor inhibitor Treatment of neovascular age-related macular degeneration. Complete Response Letter issued
OCS-01 (Oculis Holding AG) Topical corticosteroid To reduce inflammation and pain following cataract surgery. Phase 3 results
Psychiatric Disorders
Fasedienol nasal spray (Vistagen) Pherine Treatment of social anxiety disorder. Phase 3 results

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AUVI-Q https://www.empr.com/drug/auvi-q/ Thu, 22 Jul 2021 11:27:15 +0000 https://www.empr.com/drug/auvi-q/ AUVI-QEpinephrine 0.1mg, 0.15mg, 0.3mg; pre-filled auto-injector (includes audible and visible cues for use).]]> AUVI-Q]]> Azithromycin Improves Outcomes in Poorly Controlled Child Asthma https://www.empr.com/home/news/azithromycin-improves-outcomes-in-poorly-controlled-child-asthma/ Tue, 21 Jun 2022 13:00:00 +0000 https://www.empr.com/?p=182238

Better control, fewer exacerbations seen with addition of oral azithromycin to standard therapy in children with poorly controlled asthma

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HealthDay News — Azithromycin helps improve asthma control and reduce exacerbations in children with poorly controlled asthma, according to a study published in the June issue of CHEST.

Jagat Jeevan Ghimire, MD, from All India Institute of Medical Sciences in New Delhi, and colleagues randomly assigned 120 children (5 to 15 years of age) with poorly controlled asthma to receive azithromycin 3 times weekly for 3 months along with standard treatment or standard treatment alone.

The researchers found that the numbers of children with well-controlled asthma according to Global Initiative for Asthma guidelines were 41 of 56 in the azithromycin group vs 10 of 56 in the control groups. The azithromycin group had a lower median number of exacerbations requiring emergency visit and steroid use (zero vs one). There was no difference observed between the groups for fractional exhaled nitric oxide level, spirometry parameters, positive throat swab results, or adverse effects.

“The beneficial effect of azithromycin was similar in children with eosinophilic versus noneosinophilic asthma and those 5 to 11 years of age and those 12 years of age or older,” the authors write.

Abstract/Full Text (subscription or payment may be required)

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BENADRYL ALLERGY https://www.empr.com/drug/benadryl-allergy/ Thu, 23 Sep 2021 18:46:07 +0000 https://www.empr.com/drug/benadryl-allergy/ BENADRYL ALLERGY LIQUID https://www.empr.com/drug/benadryl-allergy-liquid/ Thu, 22 Jul 2021 10:11:37 +0000 https://www.empr.com/drug/benadryl-allergy-liquid/ BENADRYL ALLERGY LIQUIDDiphenhydramine HCl 12.5mg/5mL; cherry flavor; dye- and sugar-free, bubble-gum flavor; alcohol-free; contains sodium 15mg/5mL.]]> BENADRYL ALLERGY LIQUID]]> Biologics Improve Outcomes in Severe Asthma, Regardless of Age https://www.empr.com/reports/biologics-improve-outcomes-in-severe-asthma-regardless-of-age/ Fri, 23 Feb 2024 22:00:00 +0000 https://www.empr.com/?post_type=report&p=216100 Among patients with severe asthma, treatment with biologics was associated with improved asthma outcomes across all age groups, according to results presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting, held from February 23 to 26 in Washington, DC.

The CHRONICLE study (ClinicalTrials.gov Identifier: NCT03373045) is an ongoing, non-interventional, prospective, cohort study of adults with severe asthma who are currently receiving care from a specialist physician. Patients were eligible for the study if they had severe asthma for at least 12 months, were uncontrolled while receiving high-dose inhaled corticosteroids with additional controllers, and/or required systemic corticosteroids or monoclonal antibody therapy. 

To better understand the effectiveness of biologic therapy on patients with severe asthma, the researchers examined data from patients enrolled from February 2018 to February 2023 who had started a biologic. Annualized asthma exacerbation rates were compared by age group (18-49, 50-64, ≥65 years) and by biologic type (anti-immunoglobulin E [IgE] vs other biologics [anti-interleukin-5/5R/4Rs or antithymic stromal lymphopoietin]) 6 months before and after initiation of treatment. 

Results showed annualized asthma exacerbation rates were reduced in all age groups 6 months after compared with 6 months before initiating a biologic. Exacerbation rate reductions were found to trend higher among patients who received other biologics compared with those who received anti-IgE, respectively:

  • 18 to 49 years of age: 61% (P <.0001) vs 40% 
  • 50 to 64 years of age: 52% (P <.0001) vs 49% (P <.01)
  • ≥65 years of age: 58% (P <.0001) vs 51%

Study authors concluded that “Biologic use improved asthma outcomes in adult patients with [severe asthma] in all age groups, without evidence of reduced effectiveness in older age. A trend of slightly reduced effectiveness of anti-IgE vs other biologics was observed.”

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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Bypassing Oral Immunotherapy Buildup Safe in Children With Food Allergy https://www.empr.com/home/news/bypassing-oral-immunotherapy-buildup-safe-in-children-with-food-allergy/ Fri, 22 Mar 2024 13:00:00 +0000 https://www.empr.com/?p=217506 Findings from initial phase of multifood sublingual immunotherapy.

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HealthDay News — An initial phase of multifood sublingual immunotherapy (SLIT) that bypasses oral immunotherapy (OIT) buildup is safe and effective, according to a study published online February 27 in the Journal of Allergy and Clinical Immunology: In Practice.

Lianne Soller, PhD, from the University of British Columbia in Vancouver, Canada, and colleagues assessed the safety of multifood SLIT in 188 pediatric patients (aged 4 to 18 years) and the effectiveness of bypassing oral immunotherapy (OIT) buildup with an initial phase of SLIT.

The researchers found that 4 patients received epinephrine (2.10%) during buildup (2mg protein SLIT maintenance over the course of 3 to 5 visits) and went to the emergency department, although none experienced grade 4 (severe) reaction. Twenty patients had 50 low-dose oral food challenges to 300mg protein, with 70% of the oral food challenges successful in bypassing OIT buildup.

“Allergists are often quite burdened by the oral immunotherapy buildup phase, where a patient may require 11 or more visits to the clinic,” coauthor Edmond Chan, MD, also from the University of British Columbia, said in a statement. “In our clinic, we are starting to do more home-based approaches because the demand for medical appointments that would allow supervision far outstrips the supply. Our SLIT data suggests that home-based SLIT buildup is safe.”

Several authors disclosed ties to the pharmaceutical industry.

Abstract/Full Text

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Cannabis Legalization Tied to Increases in Pediatric Asthma https://www.empr.com/home/news/cannabis-legalization-tied-to-increases-in-pediatric-asthma/ Wed, 18 Jan 2023 14:00:00 +0000 https://www.empr.com/?p=190404

Increases seen compared with states where neither recreational nor medical legalization has occurred

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HealthDay News — Children’s asthma appears to be increasing in states that have legalized cannabis, according to a study published online December 30 in Preventive Medicine.

Renee D. Goodwin, PhD, from the City University of New York in New York City, and colleagues examined the relationship between cannabis legalization for medical or recreational use and the state-level prevalence of asthma among children in the US. The analysis included data from the National Survey on Children’s Health (2011 to 2019).

The researchers observed a statistically significant decrease of 1.1% in the prevalence of pediatric asthma from 2011-2012 to 2018-2019. Overall reductions in asthma over time were generally greater in states with no cannabis legalization when adjusting for sociodemographic characteristics, but the rate of decline did not differ statistically by recreational or medical legalization status. The prevalence of asthma increased among youth ages 12 to 17 years old (2018 to 2019 difference-in-difference [DID], 2.56) and youth in some minoritized race/ethnicity identity groups (2016 to 2017 DID, 3.88; 2018 to 2019 DID, 4.45) in states with recreational legalization, relative to 2011 to 2012 and to states where cannabis is illegal at the state level.

“Critical next steps in this line of research include examining whether secondhand cannabis smoke is associated with increases in asthma morbidity, such as symptom frequency, use of rescue medicines, impairment (e.g., missed school), and emergency medical services, to provide insight into the extent to which increased exposure to secondhand cannabis smoke is affecting youth health and functioning across domains,” the authors write.

Abstract/Full Text (subscription or payment may be required)

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Carbinoxamine Maleate https://www.empr.com/drug/carbinoxamine-maleate/ Thu, 22 Jul 2021 11:17:36 +0000 https://www.empr.com/drug/carbinoxamine-maleate/ Carbinoxamine Maleate Oral Solution https://www.empr.com/drug/carbinoxamine-maleate-oral-solution/ Thu, 22 Jul 2021 11:17:37 +0000 https://www.empr.com/drug/carbinoxamine-maleate-oral-solution/ CDC Reports on Prevalence of Seasonal and Food Allergies, Eczema https://www.empr.com/home/news/cdc-reports-on-prevalence-of-seasonal-and-food-allergies-eczema/ Fri, 27 Jan 2023 14:41:54 +0000 https://www.empr.com/?p=190785

18.9 percent of children and 25.7 percent of adults had seasonal allergy; 10.8 and 7.3 percent had eczema in 2021

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(HealthDay News) — In two January data briefs published by the U.S. Centers for Disease Control and Prevention National Center for Health Statistics, data are presented regarding the prevalence of seasonal allergy, eczema, and food allergy among children and adults in 2021.

Benjamin Zablotsky, PhD, from the National Center for Health Statistics in Hyattsville, Maryland, and colleagues used data from the 2021 National Health Interview Survey (NHIS) to describe the percentage of children who had diagnosed seasonal allergy, eczema, or food allergy. The researchers found that 18.9%, 10.8% and 5.8% had a seasonal allergy, eczema, and a food allergy, respectively, in 2021. The likelihood of having a seasonal allergy was higher for boys than girls (20.0% vs 17.7%). There was variation observed by age in the percentage of children with eczema (10.4%, 12.1%, and 9.8% in children aged 0 to 5, 6 to 11, and 12 to 17 years, respectively). The likelihood of having a food allergy was increased for non-Hispanic Black versus non-Hispanic White and Hispanic children.

Amanda E. Ng, MPH, and Peter Boersma, MPH, both from the National Center for Health Statistics, used 2021 NHIS data to describe the prevalence of seasonal allergy, eczema, or food allergy among adults. The researchers found that 25.7%, 7.3%, and 6.2% of adults had a seasonal allergy, eczema, and a food allergy, respectively, in 2021. Compared with Hispanic, non-Hispanic Black, and non-Hispanic Asian adults, the percentage of adults with a seasonal allergy was higher in non-Hispanic White adults. Women were more likely than men to have eczema (8.9% vs 5.7%). With increasing age, the prevalence of food allergy decreased.

“For all three allergies, women were more likely than men to have a diagnosed allergy,” Ng and Boersma write.

Data Brief – Children

Data Brief – Adults

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ChatGPT Info on Drug Allergies Reflects Guidelines Though Sources Are Questionable https://www.empr.com/reports/chatgpt-info-on-drug-allergies-reflects-guidelines-though-sources-are-questionable/ Fri, 23 Feb 2024 19:20:00 +0000 https://www.empr.com/?post_type=report&p=216080 Medical information on drug allergies provided by ChatGPT was found to reflect accepted guidelines, though the provided sources were found to have errors, according to results presented at the American Academy of Allergy, Asthma & Immunology annual meeting held from February 23 to 26, 2024 in Washington, DC.

The popularity of ChatGPT, an artificial intelligence (AI) chatbot, left researchers from the Cleveland Clinic wondering about its reliability as a medical information provider. To assess its capabilities, the researchers asked the chatbot to provide information on the prevalence, symptoms, diagnostic tests, management and prevention of drug allergies. The DISCERN instrument was used to assess the quality of the information provided by the chatbot and 4 reviewers were tasked with determining whether the AI answers matched the AAAAI/ACAAI drug allergy guidelines.

Results showed ChatGPT provided fair to good quality information (DISCERN score of 3.44/5) with 76% of the information matching guideline recommendations. “Fleiss κ score was 0.65, which represented substantial agreement between the graders of ChatGPT responses,” the authors added.

However, the chatbot failed when it came to providing accurate sources, with 60% consisting of expired web pages. Twenty-seven percent of the sources consisted of irrelevant or inaccurate links and 13% included nonspecific links.

“Artificial intelligence ChatGPT information on drug allergies appeared to reflect the currently accepted Allergy/Immunology guidelines but the chatbot was an unreliable source of information due to errors in all of the provided sources,” the authors concluded.

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CHILDREN’S ALLEGRA ODT https://www.empr.com/drug/childrens-allegra-odt/ Wed, 17 Nov 2021 21:43:15 +0000 https://www.empr.com/drug/childrens-allegra-odt/