FDA approves Biogen Idec's new multiple sclerosis treatment Tecfidera

The US Food and Drug Administration yesterday (March 27) approved biotech firm Biogen Idec’s (Nasdaq: BIIB) much awaited Tecfidera (BG-12; dimethyl fumarate), a new first-line oral treatment for multiple sclerosis, in adults with relapsing forms of MS. Two other oral MS drugs, Novartis’ Gilenya and Sanofi’s Aubagio have already been approved.

“No drug provides a cure for multiple sclerosis so it is important to have a variety of treatment options available for patients,” said Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, noting that “multiple sclerosis can impair movement, sensation, and thinking and have a profound impact on a person’s quality of life.”

The company said it will launch the drug in the USA within the coming days. The drug may be priced at $50,000 to $55,000 a year, lower than Gilenya at $58,000 and higher than Aubagio at $45,000, said Michael Yee, an RBC Capital Markets analyst in San Francisco quoted by Bloomberg. “We believe this is an attractive level of pricing given Tecfidera’s combined efficacy and safety profile,” he wrote in a research note.