Tecfidera had undergone extensive testing prior to receiving FDA approval, including studying the results of more than 2,600 patients using tecfidera, some longer than four years. The studies indicate tecfidera is successful in reducing brain lesions and minimizing relapses, and even slowing the progression of MS.
CEO of Biogen, George Scangos PhD, said, "We will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill -- a combination we believe will have a significant positive impact on the way people live with this chronic disease." Tecfidera is Biogen's fourth medication targeting MS, and is currently under regulatory review in Switzerland, Canada, and Australia.
With the FDA approval behind it, Biogen will begin making tecfidera available to U.S. patients "in the coming days," according to the announcement.