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FDA Approves Biogen Idec’s Potential Blockbuster Treatment for MS (BIIB)

Shares of Biogen Idec Inc. (NASDAQ: BIIB) gained in premarket hours on Thursday after the FDA said late on Wednesday that it has approved the biotechnology Company’s new multiple sclerosis drug, Tecfidera.

The FDA’s approval will help the Weston, Massachusetts-based Company to cement its control in the market of MS treatments since it’s a oral treatment, allowing thousands of patients suffering from MS to stop taking exiting painful treatments though injection and intravenous infusions.

The FDA said that Biogen Idec’s new treatment Tecfidera can be sold in the form of a capsule in the U.S. market and taken twice in a day.

Analysts believe that Biogen Idec’s latest MS treatment could become a blockbuster by the end of this decade should patients suffering from MS opt for capsules instead of going through existing therapies.

Meanwhile, Biogen said that its new treatment will hit the market within days.

Multiple sclerosis, which is one of the reasons behind neurological disability in young adults, is an autoimmune disorder, impacting the central nervous system. It is estimated that approximately 400,000 people in the U.S and around 2.5 million people worldwide suffer from MS disorder. It disturbs the communication between brain and other organs of the body. In most cases, MS symptoms are mainly found between the age- groups of 20-40.

Commenting over this disorder, Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center of Drug Evaluation and Research said in a stamen, “No drug provides a cure for multiple sclerosis so it is important to have a variety of treatment options available for patients.”

“Multiple sclerosis can impair movement, sensation, and thinking and have a profound impact on a person’s quality of life,” added Dr. Katz according to the

Currently, Biogen has two injectable treatments for MS: Avonex and Tysabri.


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