March 11, 2024 News by Lindsey Shapiro, PhD FDA declines to approve GA Depot as treatment for relapsing MS The U.S. Food and Drug Administration (FDA) has decided not to approve an application seeking clearance of GA Depot ā a long-acting formulation of glatiramer acetate ā for the treatment of relapsing forms of multiple sclerosis (MS). Importantly, this is not a rejection of the application for the…
August 8, 2023 News by Lindsey Shapiro, PhD FDA decision on GA Depot for relapsing MS expected March 2024 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…
March 7, 2023 News by Lindsey Shapiro, PhD ACTRIMS 2023: GA Depot found to ease MS disability in Phase 3 trial 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…
September 22, 2022 News by Marisa Wexler, MS GA Depot Reduces Relapse Rates in Phase 3 Clinical Trial 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…
April 4, 2022 Columns by Ed Tobias MS News That Caught My Eye Last Week: GA Depot, Blood-brain Barrier, Mindfulness 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…
April 1, 2022 News by Lindsey Shapiro, PhD Use of GA Depot in Treating Progressive MS Given US Patent 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, ā…
April 13, 2021 News by Patricia Inacio, PhD Phase 3 Trial of GA Depot as Monthly Relapsing MS Therapy Enrolling in US, Europe 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 withĀ clinically isolated syndromeĀ (CIS),Ā relapsing-remitting…
June 17, 2020 News by Joana Carvalho, PhD Phase 3 Trial of GA Depot for Relapsing MS Advances With $20M Support Mapi Pharma, supported by an additionalĀ $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),Ā which opened in October 2019,…
February 14, 2020 News by Ana Pena PhD Ocrevus Use Rises Among New Starters with RRMS, Loses Ground to Other Therapies in PPMS 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…
October 30, 2019 News by Alice MelĆ£o, MSc First Relapsing MS Patient Enrolled in Phase 3 Trial of Mapi Pharmaās Once-monthly Glatiramer Formulation A new Phase 3 clinical trial to explore the safety and efficacy of Mapi Pharmaās once-a-month injectable formulation of glatiramer acetate ā named GA Depot ā has started enrolling patients with relapsing multiple sclerosis (MS). The trial (NCT04121221) is expected to enroll approximately 960 participants, 18 to 55…
September 9, 2019 News by Alice MelĆ£o, MSc #ECTRIMS2019 – Mapi Pharma to Detail Latest Trial Data on GA Depot in Treating RRMS and PPMS Mapi PharmaĀ will presentĀ recent advances in its potential multiple sclerosis (MS) therapies, including GA Depot, at the 35thĀ Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) opening this week. ECTRIMS runs from Wednesday through Friday, Sept. 11ā13, in Stockholm. Among the work disclosed will be…
April 11, 2018 News by Alice MelĆ£o, MSc Mapi Pharma, Mylan Partner to Develop Once-monthly Glatiramer Formulation Mylan andĀ Mapi Pharma will jointly develop and commercialize Glatiramer Acetate (GA) Depot, an investigative, long-lasting formulation of the commonly used multiple sclerosis (MS) therapyĀ CopaxoneĀ (marketed by Teva Phatmaceutical). Under the terms of the partnership, Mylan will acquire global marketing rights for the therapy. The companies are in…
February 1, 2018 News by Jose Marques Lopes, PhD Mapi Pharma Doses First PPMS Patient in Phase 2 Trial Evaluating GA Depot The Phase 2a trial of GA Depot (glatiramer acetate) for the treatment of primary progressive multiple sclerosis (PPMS) has dosed the first patient,Ā Mapi PharmaĀ 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…
December 19, 2014 News by Patricia Silva, PhD Mapi Pharma Treats First RRMS Patient with Once-A-Month GA Depot Mapi Pharma Ltd.,Ā a development stage pharmaceutical company specializingĀ in the development of high-barrier to entry and high-added value generic drugs, announced it has treated the first patient in theĀ Phase IIa study of GA Depot forĀ relapsing-remitting multiple sclerosis (RRMS). Lead investigatorĀ ProfessorĀ Ariel Miller, M.D., Ph.D., Head of the Multiple Sclerosis & Brain…