New capsule for treating MS approved by FDA.

The AP (3/28, Perrone) reports the Food and Drug Administration approved dimethyl fumarate "to control multiple sclerosis in adults with hard-to-treat forms of the disease." The chemical will be sold by Biogen Idec as a twice-a-day capsule under the name Tecfidera. The company "already sells two other drugs for the disease, but both require injections."

        The New York Times (3/28, Pollack, Subscription Publication, 1.68M) reports, "Wall Street analysts, doctors and patients expect Tecfidera to become a blockbuster because of its combination of efficacy and relative safety and the convenience of being a pill." While dimethyl fumarate's reduction in relapse rate may not be as high as Novartis' Gilenya (fingolimod), which is also taken orally, "Gilenya has side effects that make it off limits for some patients and require careful testing and monitoring for heart, liver and eye problems." In contrast, "Tecfidera will have fewer restrictions and testing requirements."

        Similarly, Bloomberg News (3/28, Tirrell) reports analysts project dimethyl fumarate "will dominate the MS market." Timothy Coetzee, chief research officer of the National Multiple Sclerosis Society, said, "It really is going to be a great addition to the toolbox."

        However, the Wall Street Journal (3/28, Walker, Subscription Publication, 2.29M) reports that widespread use of dimethyl fumarate is expected to be gradual because patients don't tend to switch therapies if they haven't had relapses.

        In a front-page article, the Boston Globe (3/28, A1, Weisman, 250K) reports, "Most crucially, the FDA approved Tecfidera as a 'first-line' treatment, meaning doctors can prescribe it for newly diagnosed patients as well as those already taking MS drugs." The treatment is expected to cost "tens of thousands of dollars a month per patient, the bulk of it covered by insurance in most cases."

        The Los Angeles Times (3/27, Healy, 692K) reports, "Common side effects of Tecfidera are flushing and gastrointestinal events, including nausea, diarrhea and vomiting." The FDA also said that "the medication may lower white blood counts and increase infection risk."

        This story is also covered by Reuters (3/28, Clarke), the Boston Herald (3/28, Kantor, 91K), the Triangle Business Journal (3/27, Ohnesorge, Subscription Publication), MedPage Today (3/28, Gever), and Medscape (3/28, Jeffrey).