FDA approves Biogen Idec's Tecfidera

FDA approved Tecfidera dimethyl fumarate (formerly BG-12) from Biogen Idec Inc. (NASDAQ:BIIB) to treat adults with relapsing forms of multiple sclerosis. Tecfidera's label includes a warning about lymphopenia and recommends health care providers assess a patient's complete blood cell count before and during treatment, but the label does not include a black box warning. Tecfidera also does not have a REMS. Biogen Idec said it plans to launch the oral drug in the U.S. "in the coming days," but the company could not be reached for the price.

Last Friday, EMA's CHMP recommended approval of Tecfidera, which activates the NF-E2-related factor 2 (Nrf2) pathway. A European decision is expected in about two months (see BioCentury Extra, March 22). ...