The U.S. Food and Drug Administration (FDA) has decided not to approve an application seeking clearance of GA Depot — a long-acting formulation of glatiramer acetate — for the treatment of relapsing forms of multiple sclerosis (MS). Importantly, this is not a rejection of the application for the…

The U.S. Food and Drug Administration (FDA) has agreed to review Viatris and Mapi Pharma‘s application seeking approval of GA Depot for the treatment of relapsing forms of multiple sclerosis (MS). The medication is a long-acting formulation of glatiramer acetate, the active ingredient in the approved…

GA Depot, an experimental long-acting version of glatiramer acetate, significantly reduced relapse rates and prevented the development of new lesions among people with relapsing forms of multiple sclerosis, according to new data from a Phase 3 clinical trial. Disability levels also were significantly reduced with the treatment, given…

Treatment with GA Depot, an experimental long-acting form of glatiramer acetate that requires less frequent dosing than approved formulations, significantly reduced relapse rates among people with relapsing forms of multiple sclerosis (MS), according to top-line results from a Phase 3 clinical trial. “We are pleased with the topline…

Use of GA Depot in Treating Progressive MS Given US Patent In the area of MS treatments, one major need is for medications that treat more than just the relapsing form of our disease. GA Depot might help fill that void. The U.S. patent the medication received says it’s…

Mapi Pharma announced that it has been granted a U.S. patent covering the use of GA Depot, a potential long-acting formulation of glatiramer acetate, in people with progressive forms of multiple sclerosis (MS). The U.S. Patent and Trademark Office patent, No. 11,167,003, is titled, “…

A Phase 3 trial investigating GA Depot, a long-acting, once-a-month injectable formulation of glatiramer acetate, is seeking patients with relapsing forms of multiple sclerosis (MS). The global study (NCT04121221) aims to include 960 adults, ages 18 to 55, diagnosed with clinically isolated syndrome (CIS), relapsing-remitting…

Mapi Pharma, supported by an additional $20 million investment from its partner Mylan, will continue a Phase 3 trial assessing the safety, tolerability, and efficacy of GA Depot, its long-acting, once-a-month injectable formulation of glatiramer acetate. The study (NCT04121221), which opened in October 2019,…

First-line use of Genentech‘s Ocrevus (ocrelizumab) for patients with multiple sclerosis (MS) has remained stable through 2019 compared to 2018, according to the latest Spherix Global Insights‘ report. However, the latest edition of “RealWorld Dynamix: DMT New Starts in Multiple Sclerosis (US),” based…

A new Phase 3 clinical trial to explore the safety and efficacy of Mapi Pharma’s once-a-month injectable formulation of glatiramer acetate — named GA Depot — has started enrolling patients with relapsing multiple sclerosis (MS). The trial (NCT04121221) is expected to enroll approximately 960 participants, 18 to 55…

Mapi Pharma will present recent advances in its potential multiple sclerosis (MS) therapies, including GA Depot, at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) opening this week. ECTRIMS runs from Wednesday through Friday, Sept. 11–13, in Stockholm. Among the work disclosed will be…

Mylan and Mapi Pharma will jointly develop and commercialize Glatiramer Acetate (GA) Depot, an investigative, long-lasting formulation of the commonly used multiple sclerosis (MS) therapy Copaxone (marketed by Teva Phatmaceutical). Under the terms of the partnership, Mylan will acquire global marketing rights for the therapy. The companies are in…

The Phase 2a trial of GA Depot (glatiramer acetate) for the treatment of primary progressive multiple sclerosis (PPMS) has dosed the first patient, Mapi Pharma recently announced. In the U.S., Copaxone (glatiramer acetate injection, marketed by Teva Pharmaceutical) is the standard therapy for relapsing-remitting multiple sclerosis (RRMS), which is…

Mapi Pharma Ltd., a development stage pharmaceutical company specializing in the development of high-barrier to entry and high-added value generic drugs, announced it has treated the first patient in the Phase IIa study of GA Depot for relapsing-remitting multiple sclerosis (RRMS). Lead investigator Professor Ariel Miller, M.D., Ph.D., Head of the Multiple Sclerosis & Brain…