FDA Accepts New Drug Application for GA Depot to Treat Relapsing Multiple Sclerosis

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for GA Depot 40 mg (Viatris, Canonsburg, PA; Mapi Pharma, Ness Ziona, Israel) to treat relapsing multiple sclerosis (RMS). This long-acting glatiramer acetate is under evaluation for the treatment of RMS as a once-monthly intramuscular injection version of commercially available Copaxone (glatiramer acetate injection; Teva Neuroscience, Parsippany, NJ).

In considering the NDA for GA Depot, the FDA reviewed data from a multinational, double-blind, placebo-controlled phase 3 clinical trial (NCT04121221) that assessed the safety, efficacy, and tolerability of the drug in treating RMS. The study included 1016 participants randomized to receive an intramuscular injection every 4 weeks of either 40 mg of GA Depot or placebo for up to 52 weeks. GA Depot met the primary endpoint of the study by reducing the annualized relapse rate (ARR) in patients with RMS by 30.1% compared with placebo (P=.0066). In terms of secondary endpoints, analysis of study results indicated a statistically significant reduction of 28.5% in the cumulative number of T1 new enhancing lesions in the GA Depot arm compared with those assigned to placebo, according to MRI scans (P=.0083). The most common treatment emergent adverse events were injection site reactions.

“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.

The FDA established a target Prescription Drug User Fee Act (PDUFA) action date of March 8, 2024 for their decision.