Federal regulators Wednesday approved Biogen Idec Inc.’s first pill to treat multiple sclerosis, a decision that cements the Weston biotechnology company’s dominance in the market for MS treatments and could allow thousands of patients to stop taking drugs by needle or through intravenous infusions.
The Food and Drug Administration said Biogen Idec can sell the treatment, called Tecfidera, in the United States in the form of a capsule to be taken twice a day. Analysts have projected Tecfridera could become one of the best-selling drugs of all time by the end of the decade if MS patients shift from existing therapies now on the market.
The company said it expects to start making the drug available within days.
MS, one of the most common causes of neurological disability in young adults, is an autoimmune disorder that affects the central nervous system of about 400,000 people in the United States and 2.5 million globally. It disrupts communication between the brain and other parts of the body. Most people experience their first MS symptoms between the age of 20 and 40.
“No drug provides a cure for multiple sclerosis so it is important to have a variety of treatment options available for patients,” Dr. Russell Katz, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Multiple sclerosis can impair movement, sensation, and thinking and have a profound impact on a person’s quality of life.”
Biogen Idec already markets two injectable MS drugs, Avonex and Tysabri.