FDA accepts review of Viatris and Mapi’s NDA filing for GA Depot

08 Aug 2023
www.pharmaceutical-technology.com
NDAPhase 2Phase 3
FDA accepts review of Viatris and Mapi’s NDA filing for GA Depot
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Source: Pharmaceutical Technology
GA Depot is intended for the treatment of relapsing forms of multiple sclerosis. Credit: Zerbor/Shutterstock.com.
The US Food and Drug Administration (FDA) has accepted for review Viatris and Mapi Pharma’s new drug application (NDA) which has been filed for GA Depot.
A Prescription Drug User Fee Act target action date of 8 March 2024 was assigned by the FDA.
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View allCompanies IntelligenceViatris IncMapi Pharma LtdgAMAPI SASView all
The 40mg product is a long-acting glatiramer acetate (GA) to treat relapsing forms of multiple sclerosis (RMS/MS). It is administered as a monthly injection.
The filing is supported by data from a Phase III study that compared the safety, tolerability and efficacy of GA Depot with placebo.
This multinational, double-blind, placebo-controlled study enrolled 1,016 subjects who received either 40mg of GA Depot or a placebo.
Both groups received the treatment once every four weeks for a total of 13 doses via intramuscular injection.
The product offered a preferable schedule and anticipated fewer injection site reactions than other GA candidates.
A statistically significantly reduced annualised relapse rate of 30.1% against placebo (p=0.0066) was observed, a primary endpoint of the study.
Mapi Pharma CEO and chairman Ehud Marom stated: “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.
“I commend the teams at Mapi and Viatris for the strong collaboration which has leveraged our collective expertise in complex products to deliver this novel medicine.”
Commercially available as Copaxon, GA Depot is a long-acting injection version of the approved GA.
It is also currently being studied in a Phase II trial in patients with primary progressive multiple sclerosis.
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