FDA Orders New Label For Biogen Idec's MS Drug

Biogen Idec Inc BIIB was little changed Tuesday when regulators ordered new labeling information for its blockbuster multiple sclerosis treatment Tecfidera concerning a patient's death from a brain infection.

Biogen disclosed the incident October 22 in a conference call with analysts.

Chief Executive George A. Scangos told analysts that despite the death, "we believe that the overall positive benefit risk profile of Tecfidera remains unchanged."

The drug has been taken by more than 100,000 patients within just 18 months of the U.S. launch, Scangos said.

The patient died of progressive multifocal leukoencephalopathy, or PML, after taking Tecfidera for more than four years in a long-term study.

The U.S. Food and Drug Administration on Tuesday ordered that new labeling information that describes the event be added to Tecfidera.

"This is the only confirmed case reported in patients taking Tecfidera," the FDA said.

Tecfidera, approved for U.S. marketing in March 2013, accounted for $787 million of Biogen's $2.51 billion in third-quarter revenue.

The drug currently has about a 50 percent market share as a second-line treatment for multiple sclerosis and a 7 percent share as a first-line treatment, according to the market research concern Decision Resources Group.

Biogen traded recently at $304.94, down 0.6 percent.