Tecfidera dimethyl fumarate regulatory update
The U.K.'s NICE said it is "minded not to recommend" Tecfidera dimethyl fumarate from Biogen Idec for relapsing-remitting multiple sclerosis (RRMS), but said it needs more information before it can make a final recommendation. According to draft guidance, NICE requested further clarification from Biogen Idec, including cost-effectiveness estimates for "several plausible treatment sequences" that reflect U.K. clinical practice - for instance, Tecfidera, beta interferon and Gilenya fingolimod from Novartis AG (NYSE:NVS; SIX:NOVN, Basel, Switzerland) compared with beta interferon, Gilenya and Copaxone glatiramer acetate from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA, Petah Tikva, Israel) and Sanofi (Euronext:SAN; NYSE:SNY, Paris, France). NICE also requested that Biogen Idec provide results from the Phase III DEFINE and CONFIRM trials of Tecfidera adjusted for baseline relapse rate. CONFIRM compared Tecfidera to placebo and Copaxone, and DEFINE compared Tecfidera to placebo.
Biogen Idec has already agreed to provide Tecfidera with an undisclosed discount under a patient access scheme. Comments and the requested information are due March 12. Final guidance is expected this summer. The European Commission approved Tecfidera earlier this month (see BioCentury, Feb. 10). ...