March 30, 2017

FDA approves first drug for severe MS

Daily Briefing

    FDA on Tuesday approved Genentech's multiple-sclerosis (MS) drug, Ocrevus, as the first treatment for primary progressive MS, the most severe form of the disease, for sale in the United States.

    FDA also approved the drug to treat the more common, relapsing form of the disease, according to the New York Times.

    About MS

    About 400,000 U.S. residents have MS, and roughly 15 percent of those individuals have the primary progressive form of the disease.

    The disease typically affects people between ages 20 and 50, but can develop as late as 75. Symptoms of MS vary in severity but often include loss of balance, poor coordination, fatigue, and weakness. The relapsing form of the disease can flare up and recede unpredictably, according to the Wall Street Journal, whereas the primary progressive form takes a relatively constant course. National MS Society President and CEO Cyndi Zagieboylo said the primary progressive form of MS is "just a steady worsening" of the disease. Most patients end up needing a cane or crutches to walk, while others can become severely disabled, the Journal reports.

    Ocrevus details

    According to the Times, Ocrevus, known generically as ocrelizumab, is an injectable drug that treats MS by depleting a type of B cell, which is part of the immune system, that is believed to malfunction and contribute to central nervous system damage in individuals with MS.

    A clinical trial for individuals with primary progressive MS found that those who took Ocrevus had 24 percent less risk of MS progressing when compared with patients who received a placebo. In addition, trails showed that individuals with relapsing MS who took Ocrevus had a 47 percent reduction in their rate of relapses compared with patients who took Rebif, an existing treatment for the disease.

    According to the Times, many of the most effective existing treatments currently available for relapsing MS have several side effects, as a result, physicians often wait for the disease to progress before prescribing patients the drugs. Ocrevus is considered relatively safe, the Times reports, with side effects including reactions at the injection site, upper respiratory infections, and cold sores.

    Pricing

    Genentech plans to price Ocrevus at $65,000 for a year's worth of treatment, which is about one-quarter less than a year's worth of Rebif.

    Genentech in a statement noted that MS drug prices have risen in recent years. The company said, "We feel that the industry needs to start to reverse this trend, and believe that pricing Ocrevus 25 percent less than the comparator [used] in our trials is an important first step."

    Reaction

    Zagieboylo called FDA's approval of Ocrevus "a real game-changer." She said, "This is an historic day for the MS community with the approval of the first-ever treatment for people living with primary progressive MS."

    Stephen Hauser—chair of the neurology department at the University of California-San Francisco who led the steering committee that oversaw late-stage clinical trials of the generic ocrelizumab—said, "The magnitude of the benefits that we've seen with ocrelizumab in all forms of MS are really quite stunning."

    Steven Galetta, chair of the neurology department at New York University's Langone Medical Center and an MS expert, said, "I think if the safety holds up, [Ocrevus] will become the leading MS therapy" (Burton, Wall Street Journal, 3/28; Thomas, New York Times, 3/28).

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