Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Teva Pharmaceutical Industries has completed patient enrollment in an international Phase III trial evaluating the efficacy, safety and tolerability of 40mg COPAXONE (glatiramer acetate injection) administered three times a week compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS).
Subscribe to our email newsletter
Patient enrollment was completed in May 2011, recruiting over 1,400 patients at 180 sites in the US, Europe, Central Eastern Europe and Israel.
The primary endpoint of the GALA (glatiramer acetate low-frequency administration) trial is the total number of confirmed relapses during a 12-month placebo-controlled phase, which will be followed by an open-label extension phase.
Results from the trial are expected in the second quarter of 2012.
COPAXONE is now approved in more than 50 countries worldwide, including the US, Russia, Canada, Mexico, Australia, Israel and all European countries.
In North America, COPAXONE is marketed by Teva Neuroscience, which is a subsidiary of Teva Pharmaceutical Industries.
In Europe, the product is marketed by Teva Pharmaceutical Industries and sanofi-aventis.