EMA advisory backing for Biogen's Tecfidera, Sanofi's Aubagio and Gilead's Stribild; extends use of Bayer's Xarelto; negative for Kynamro

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) said on Friday that it is recommending a marketing authorization be granted for US biotech firm Biogen Idec’s (Nasdaq: BIIB) Tecfidera (dimethyl fumarate) as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMP, on the basis of quality, safety and efficacy data submitted by Biogen Idec, considers there to be a favorable benefit-to-risk balance for the drug.

As follows all CHMP recommendations, this is now referred to the European Commission, which grants marketing authorization for medicines in the European Union. The US Food and Drug Administration is expected to make a decision on the marketing application for Tecfidera in the coming days. Cowen & Co analyst Eric Schmidt estimates that Tecfidera could achieve annual peak sales of $3.2 billion a year by 2017.

"With the CHMP's positive opinion for Tecfidera, we are one step closer to offering the European MS community a treatment with compelling 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," said George Scangos, chief executive of Biogen Idec.