The updated label now includes 3-year data from AURORA 2, a double-blind, placebo-controlled extension study.
Immune Disorders
— DRUG MONOGRAPHS BY SUBSECTION —
News and Features
Cases of ICP were reported in pregnant patients receiving azathioprine or 6-mercaptopurine to treat inflammatory bowel disease or systemic lupus erythematosus.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 4WHILM trial.
The phase 3 SELECT-GCA study evaluated the efficacy and safety of upadacitinib in patients 50 years of age and older with GCA.
Asthma treatment gains approval for severe cases in pediatrics; Dovato gains expanded indication; Decision taken to remove ALS drug from market; Complete Response Letter issued for apomorphine device; At-home Mpox test kit made available.
Nasal spray approved for chronic rhinosinusitis; Endothelin receptor antagonist gains approval to lower blood pressure in hypertension; One-time stem cell treatment approved for metachromatic leukodystrophy; NASH treatment gains accelerated approval; New automated insulin delivery system for type 1 diabetes.
The table below is a review of notable updates that occurred in February 2024 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.
Asceniv and Bivigam are indicated for the treatment of primary humoral immunodeficiency in adults and adolescents.
The PDUFA date refers to the deadline set by the US Food and Drug Administration for reviewing drug applications.
The application is supported by data from the phase 2 AGAVE-201 study.
Beneficial outcomes seen for patients with systemic lupus erythematosus, idiopathic inflammatory myositis, systemic sclerosis.
The sBLA is supported by data from the ADHERE study which evaluated the efficacy and safety of the SC formulation in 322 adults with CIDP.
Sibeprenlimab is a humanized IgG2 monoclonal antibody that reduces the production of galactose deficient IgA1 by binding to and neutralizing a proliferation-inducing ligand.
The approval was based on data from the phase 3 ADVANCE-CIDP 2 study, which included 18 adults with CIDP who developed a relapse in the ADVANCE-CIDP 1 study after receiving treatment with HyQvia.
Avacopan plus rituximab offers a superior remission rate at 52 weeks and lower risk of relapse compared with prednisone taper plus rituximab, with a similar safety profile.
The approval was based on data from the placebo-controlled ADVANCE-1 trial and a single-arm, open-label, extension study.
The US Food and Drug Administration (FDA) approved a wide range of therapies in 2023, including many new molecular entities and biological products. The information below is organized by the month in which the product received approval.
Hizentra is indicated for primary immunodeficiency and chronic inflammatory demyelinating polyneuropathy.
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