BioCentury
ARTICLE | Company News

No CHMP recommendation yet on Teva's laquinimod

December 21, 2013 2:24 AM UTC

Active Biotech AB (SSE:ACTI) said partner Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) was notified by EMA's CHMP that the committee has not reached a decision on an MAA for laquinimod to treat relapsing-remitting multiple sclerosis (RRMS). Active Biotech said it expects CHMP to issue an opinion at the committee's January 2014 meeting. In November 2011, Teva abandoned plans to submit an NDA to FDA for laquinimod, but the partners then reached an agreement with FDA on a third Phase III trial of the compound. Teva and Active Biotech started the Phase III CONCERTO trial earlier this year (see BioCentury Extra, Aug. 8, 2012). ...