Tecfidera dimethyl fumarate regulatory update

The U.K.'s NICE published final guidance recommending Tecfidera dimethyl fumarate from Biogen Idec to treat relapsing-remitting multiple sclerosis (RRMS) in a subgroup of patients who do not have highly active or rapidly evolving severe RRMS. The guidance is in line with a final appraisal determination issued in July (see BioCentury, July 14). The recommendation is contingent on the company providing Tecfidera at an undisclosed discount under a patient access scheme. The committee said there was insufficient evidence to recommend Tecfidera in highly active or rapidly evolving RRMS. ...