The Food and Drug Administration (FDA) has accepted for review the New Drug Application for glatiramer acetate (GA) Depot 40mg for the treatment of relapsing forms of multiple sclerosis (RMS).
GA Depot 40mg is a long-acting version of FDA-approved Copaxone intended to be administered intramuscularly (IM) once every 4 weeks. The application is supported by data from a randomized, double-blind phase 3 trial (ClinicalTrials.gov Identifier: NCT04121221), which evaluated the efficacy and safety of GA Depot 40mg in 1016 adults with RMS. Study participants were randomly assigned to receive either GA Depot 40mg or placebo via IM injection every 4 weeks for a total of 13 doses. Tetracaine Powder
Results showed that treatment with GA Depot statistically significantly reduced annualized relapse rate (primary endpoint) by 30.1% compared with placebo (P =.0066). Key secondary endpoints were also met with a 28.5% reduction in cumulative T1 new enhancing lesions (P =.0083); a 17.3% reduction in cumulative new or newly enlarging hyperintense T2 lesions at week 52 (P =.0305); and a significant reduction in mean expanded disability status scale score (P =.0193). The most common adverse reaction reported with GA Depot was injection site reaction.
“We are confident that GA Depot, when approved, will represent an important advancement in MS care by offering a convenient once-monthly option for patients which may potentially improve compliance and adherence, and the medicine is well positioned to deliver on this important unmet need,” said Ehud Marom, CEO and Chairman, Mapi Pharma.
A regulatory decision is expected on March 8, 2024.
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