Laquinimod European MAA formal review to commence

European Medicines Agency (EMA) has completed MAA validation process and acceptance for review of the relapsing-remitting multiple sclerosis (RRMS) treatment candidate laquinimod of Teva Pharmaceuticals (NASDAQ: TEVA) and Active Biotech (OMX: ACTI), the Swedish company said in a release. The filing is based on a pooled-date from two global phase 3 clinical trials involving over 2400 patients. This means a formal scientific review process will begin. Active Biotech will receive a 5 million USD milestone as a result. In the United States, the companies are communicating with the FDA on how to proceed (basically what kind of trial to run) with the compound, as the agency there simply pointed out that the other trial missed primary endpoint and thus was not approvable at the time.