FDA Drug Approval Decisions Expected in January 2024

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. The typical period for review is 10 months after the drug application has been accepted by the Agency. For drugs that have Priority Review, the review period is reduced to 6 months from the time of application acceptance.

Berdazimer Gel for the Treatment of Molluscum Contagiosum

PDUFA date: January 5, 2024

Berdazimer gel is an investigational nitric oxide-releasing topical antiviral gel. The NDA is supported by data from the phase 3 B-SIMPLE4 study (ClinicalTrials.gov Identifier: NCT04535531), which evaluated the efficacy and safety of berdazimer gel 10.3% applied topically once daily in 891 patients 6 months of age and older with molluscum contagiosum. Findings showed that a greater proportion of patients treated with berdazimer gel achieved complete clearance of all treatable molluscum lesions at week 12 compared with those who received vehicle gel (primary endpoint). 

Zolbetuximab for Gastric and Gastroesophageal Junction Cancer

PDUFA date: January 12, 2024

Zolbetuximab is a chimeric IgG1 monoclonal antibody that binds to CLDN18.2 on the cancer cell surface of gastric epithelial cells. This action results in antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. The BLA is supported by data from two phase 3 trials: GLOW (ClinicalTrials.gov Identifier: NCT03653507) and SPOTLIGHT (ClinicalTrials.gov Identifier: NCT03504397). In GLOW, treatment with zolbetuximab plus capecitabine and oxaliplatin (CAPOX) significantly improved progression free survival (PFS) and prolonged overall survival (OS) compared with placebo plus CAPOX. In SPOTLIGHT, statistically significant improvements in PFS and OS were also observed with zolbetuximab plus oxaliplatin, leucovorin and fluorouracil (mFOLFOX6) compared with placebo plus mFOLFOX6.

Dihydroergotamine Nasal Powder (STS101) for Acute Treatment of Migraine

PDUFA date: January 17, 2024

STS101 is an investigational dihydroergotamine (DHE) nasal powder product that is administered via a proprietary nasal delivery device. According to Satsuma Pharmaceuticals, the dry powder DHE formulation is expected to provide fast absorption and robust efficacy compared with existing DHE products. The NDA is supported by data from a long-term, open-label, phase 3 trial (ClinicalTrials.gov Identifier: NCT04406649), which included 446 adults with at least a 1 year history of migraine with or without aura. Data from the double-blind, placebo-controlled phase 3 SUMMIT trial (ClinicalTrials.gov Identifier: NCT04940390) were also included in the submission; results from this study did not meet statistical significance.

Intranasal Scopolamine (DPI-386 Nasal Gel) for Motion Sickness Prevention

PDUFA date: January 26, 2024

DPI-386 gel was evaluated in a phase 3, double-blind, placebo-controlled study (ClinicalTrials.gov Identifier: NCT05548270) that included approximately 500 adults who were exposed to motion on an ocean voyage. Study participants were randomly assigned to self-administer the scopolamine nasal gel (containing 0.2mg of scopolamine HBr per 0.12g of gel) or placebo. Findings showed the proportion of patients who did not report vomiting and did not request rescue medication (primary endpoint) was significantly greater in the intranasal scopolamine arm compared with the placebo arm. Pharmacokinetic studies also demonstrated rapid absorption when scopolamine was administered intranasally.

Low Dose Atropine 0.01% (NVK002) for Children With Myopia

PDUFA date: January 31, 2024

The application for NVK002 is supported by data from the double-masked, placebo-controlled phase 3 CHAMP study (ClinicalTrials.gov Identifier: NCT03350620), which included nearly 600 children 3 to 17 years of age with myopia. Study participants were randomly assigned to receive NVK-002 or placebo once nightly. Three-year data showed that NVK002 at a dose of 0.01% achieved statistically significant and clinically meaningful differences compared with placebo for key outcome measures, including responder analysis, mean change from baseline in Spherical Equivalent Refraction, and mean change from baseline in axial length. Recently announced 4-year data indicate a continued widening of these treatment effects.

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