A Pembroke mother, whose 19-year-old son suffers from Duchenne muscular dystrophy, is headed to Washington, D.C., to ask lawmakers to urge federal regulators to speed up the approval process for a drug that has shown potential to stop the advance of the fatal genetic disease.
Christine McSherry's trip comes after the drug's maker, Cambridge-based Sarepta Therapeutics, revealed Monday that it does not expect to submit a new-drug application for eteplirsen until mid-2015, because the Food and Drug Administration has asked for more data.
"There hasn't been any adverse reactions in any of the patients taking this drug," said McSherry, who will be on Capitol Hill tomorrow. "The only thing that's changed in two years is boys like my son, Jett, who are not on the drug have continued to decline, while boys on the drug have continued to be stable."
Sandy Walsh, an FDA spokeswoman, said the agency "is fully committed to make safe and effective drugs available for patients with Duchenne muscular dystrophy as soon as possible."
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