Health Canada has approved Teva Canada Innovation‘s three-time weekly 40 mg/mL injection of Copaxone (glatiramer acetate) that allows less frequent dosing for patients with relapsing-remitting multiple sclerosis (RRMS).
The approval was 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 Copaxone 40 mg/mL or a placebo for 12 months.
Researchers found the regimen to be safe and effective for 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 for injections three times each week 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 a press release, the new formulation of Copaxone 40 mg/mL is expected to be available for patients later this year. Copaxone 20 mg/mL will continue to be available.
Additionally, patients can benefit from Teva Canada Innovation’s support program called Shared Solutions that will be available to anyone impacted by 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.