FDA approves Tecfidera (Biogen IDEC) to treat relapsing Multiple Sclerosis

Biogen Idec has announced that the FDA has on 27 March 2013, approved Tecfidera (dimethyl fumarate), a new first-line oral treatment for people with relapsing forms of Multiple Sclerosis .

The FDA approval of Tecfidera is based on data from a robust clinical development program that included DEFINE and CONFIRM, two global Phase III studies that enrolled more than 2,600 patients. In the ongoing extension study, ENDORSE, some patients receiving Tecfidera have been followed for more than four years.

On March 22, 2013 the Committee for Medicinal Products for Human Use in the European Union issued a positive opinion recommending a marketing authorization be granted for Tecfidera as a first-line oral treatment for adults with relapsing-remitting Multiple Sclerosis.