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

The submission is backed by findings from a Phase III trial that examined the safety and effectiveness of GA Depot in comparison to a control group.

The FDA in the United States has agreed to assess the application for Viatris and Mapi Pharma's latest medication known as GA Depot.

The FDA has set a deadline of 8 March 2024 for taking action on the Prescription Drug User Fee Act.

The 40mg item is a sustained-release glatiramer acetate (GA) medication meant for relieving symptoms of relapsing types of multiple sclerosis (RMS/MS). It is given through a monthly shot.

The document is backed by information gathered from a Phase III investigation which examined the safety, tolerability, and effectiveness of GA Depot in comparison to a dummy treatment.

In this global, trial where neither the researchers nor the participants were aware of the treatment assignment, a total of 1,016 individuals took part. They were randomly given either 40mg of GA Depot or a fake treatment without any active ingredients.

Both sets of participants were given the therapy once in every four weeks, with a total of 13 administrations through injections into the muscles.

The product provided a more desirable timetable and expected to cause fewer adverse reactions at the injection site compared to other medications being considered for general anesthesia.

The study showed a significant decrease in the annual relapse rate of 30.1% compared to the placebo group (p=0.0066), which was a main focus of the research.

The CEO and chairman of Mapi Pharma, Ehud Marom, expressed his belief that the approval of GA Depot would be a significant step forward in multiple sclerosis (MS) treatment. This treatment option, taken once a month, could greatly enhance patients' adherence to their medication regimen. As a result, it has the potential to effectively address an important aspect of MS care that is currently not adequately met.

I admire the cooperation between Mapi and Viatris teams for working together and utilizing our combined knowledge in complicated products to create this innovative medication.

Sold under the brand name Copaxon, GA Depot is a sustained-release injection variant of the authorized GA drug.

Additionally, it is presently undergoing examination in a Phase II experiment on individuals suffering from primary progressive multiple sclerosis.