FDA Approves Biogen Treatment for MS

By Dow Jones Business News, March 27, 2013, 04:22:00 PM EDT

By Kristin Jones

The U.S. Food and Drug Administration has approved Biogen Idec Inc.'s ( BIIB ) new treatment for relapsing forms of multiple sclerosis in adults.

The FDA approved Tecfidera, or dimethyl fumarate, capsules after two clinical trials showed that people taking the drug had fewer relapses compared with a placebo. One trial showed that those taking the drug were less likely to experience a worsening of disability.

"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, who directs the neurology products division in the FDA'sCenter for Drug Evaluation and Research.

Multiple sclerosis is a chronic disease that affects the central nervous system, causing muscle weakness and difficulty with coordination and balance. The disease is among the most common causes of neurological disability in young adults, affecting more women than men, the FDA said.

Tecfidera's most common side effects were flushing as well as stomach problems, including vomiting and diarrhea, the FDA said. The drug may decrease a person's white blood-cell count, which can raise the risk of infection.

Biogen reported in January that its fourth-quarter earnings fell 2.7% as the biotechnology company amped up its promotional planning and sales force in preparation to launch Tecfidera.

Competitor Teva Pharmaceutical Industries Ltd. (TEVA, TEVA.TV) in January formally asked the FDA to deny Tecfidera's approval because of the potential for kidney problems, found in animal testing.

Biogen shares closed Wednesday up 3.2% at $182.68. The stock is up 25% so far this year.

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FDA Approves Biogen Treatment for MS