The U.S. Food & Drug Administration (FDA) will review a medication called GA (glatiramer acetate) Depot and its impact on relapsing forms of multiple sclerosis (MS) and primary progressive MS.
In an Aug. 8 announcement, Multiple Sclerosis News Today said the FDA’s decision — on a 40mg dose administered intramuscularly once per month — is expected in March 2024. The FDA application was put forth by Viatris and Mapi Pharma.
MS News Today noted that the long-acting glatiramer acetate formulation is the active ingredient in Copaxone, an approved therapy administered subcutaneously once per day or three times per week. Viatris and Mapi Pharma believe there are advantages to a monthly dosage instead.
Mapi Pharma’s CEO/Chairman, Ehud Marom, said in an Aug. 7 Viatris news release, “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.”