CHMP recommends Tecfidera(Biogen IDEC) for treatment of Multiple Sclerosis

Biogen Idec has announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) recommending a marketing authorization be granted for 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 Tecfidera.

The CHMP opinion for Tecfidera is based on data from a large clinical development program that included two global Phase III studies, DEFINE and CONFIRM, involving more than 2,600 RRMS patients, as well as an ongoing extension study in which some patients have been followed for more than four years.