News Teva’s New Copaxone Formulation for RRMS Approved by Health Canada Teva’s New Copaxone Formulation for RRMS Approved by Health Canada by Patricia Silva, PhD | August 25, 2016 Share this article: Share article via email Copy article link Health Canada has approved Teva Canada Innovation‘sĀ three-time weekly 40 mg/mL injection of Copaxone (glatiramer acetate) that allows less frequent dosing forĀ patients with relapsing-remitting multiple sclerosis (RRMS). The approval wasĀ grounded primarily on data resulting from the Phase 3 Glatiramer Acetate Low-Frequency Administration (GALA) study, the largest Copaxone clinical trial conducted. The study included more than 1,400 patients with (RRMS). The randomized, double-blind trial (NCT01067521) was conducted at 142 sites in 17 countries. RRMS patients with at least one documented relapse in the year before screening, or at least two documented relapses two years before screening, and an Expanded Disability Status Scale score equal or above 5.5 were randomized to receive injected CopaxoneĀ 40 mg/mL or a placebo for 12 months. Researchers foundĀ the regimen to be safe and effective forĀ RRMS with the convenience of fewer injections per week compared to the current formulation of Copaxone 20 mg/mL. Copaxone 40 mg/mL is prescribed forĀ injections three times each weekĀ taken at least 48 hours apart. Common side effects include redness, pain, swelling, itching, or a lump at the site of the injection. Chest pain and other side effects were also reported. According to aĀ press release, the new formulationĀ of Copaxone 40 mg/mL is expected to be available forĀ patients later this year.Ā Copaxone 20 mg/mL will continue to be available. Additionally,Ā patients canĀ benefit from Teva Canada Innovationās support program called Shared Solutions thatĀ will be available to anyone impacted byĀ MS including family members, friends, caregivers, and health professionals. Copaxone is approved in more than 50 countries worldwide. It was approved by theU.S. Food and Drug Administration (FDA) in January 2014. In Europe, the Medicines and Health products Regulatory Agency (MHRA) and certain member states issued a positive assessment report under the decentralized procedure in December 2014. Teva Canada Innovation is the Canadian subsidiary of Teva Pharmaceutical Industries. Print This Page About the Author Patricia Silva, PhD PatrĆcia holds a PhD in medical microbiology and infectious diseases from the Leiden University Medical Center, Netherlands, and completed a postdoctoral research fellowship at the Instituto de Medicina Molecular, Lisbon, Portugal. Her work in academia was mainly focused on molecular biology and the genetic traits of infectious agents such as viruses and parasites. PatrĆcia earned several travel awards to present her work at international scientific meetings. She is a published author of several peer-reviewed science articles. Tags Canada, Glatiramer acetate, RRMS
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