FDA assigns PDUFA target action date of March 8, 2024
New Drug Application supported by positive Phase III efficacy and safety clinical trial results
Milestone builds upon Viatris’ long-standing and continued commitment toward addressing the unmet needs of the MS community
PITTSBURGH and NESS ZIONA, Israel, Aug. 7, 2023 /PRNewswire/ — Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Mapi Pharma Ltd., a fully integrated, late-stage clinical development pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ recently submitted New Drug Application (NDA) for GA Depot 40 mg. The product is a long-acting glatiramer acetate being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis (RMS). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 8, 2024.
Viatris President Rajiv Malik said, “The NDA filing acceptance for GA Depot is yet another example of our continuous commitment to look for opportunities to enhance existing therapies and innovation to support unmet medical needs. Our application is backed by Phase III efficacy and safety data, and we believe, when approved, GA Depot could improve patient experience through fewer injections, greater tolerability and increased compliance. This milestone gives us further confidence in the strength of our GA Depot clinical program, and we look forward to continuing to work closely with FDA to bring access to this important complex medicine to patients.”
According to a landmark study funded by the National Multiple Sclerosis Society, nearly one million people are living with MS in the U.S., which is more than twice as many people than was previously thought.1 Approximately 85 percent of people with MS are initially diagnosed with relapsing-remitting multiple sclerosis.2
The GA Depot NDA filing is supported by results from a multinational, double blind, placebo-controlled Phase III clinical trial evaluating the efficacy, safety and tolerability of GA Depot compared with placebo in patients with RMS. A total of 1,016 subjects were randomized into two groups, receiving either 40mg of GA Depot or placebo, via intramuscular injection (IM), once every 4 weeks for a total of 13 doses. The study concluded that the product offers a preferable schedule and with expected fewer Injection Site Reactions than other GA products. The study met its primary endpoint showing that GA Depot 40 mg statistically significantly reduced the annualized relapse rate by 30.1 percent compared to placebo (p=0.0066).
“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. “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.”