Northbrook, Ill.-based Marathon Pharmaceuticals holds the U.S. rights to deflazacort, a steroid already available to treat Duchenne muscular dystrophy outside of the United States. If approved, the drug would be the first of its kind available in the country to treat the disease.
Currently, there are no treatments for Duchenne muscular dystrophy on the market in the United States. Patients with the disorder are treated with Prednisone, which is not specifically approved to treat the illness and can cause more weight gain as a side effect than deflazacort, said Valerie Cwik, executive vice president of the Muscular Dystrophy Association.
Under priority review status, Marathon will learn whether the drug applications for both the tablet and liquid form of deflazacort are approved within six months, instead of 10. Marathon expects to hear from the FDA in February.
Eteplirsen — a second Duchenne muscular dystrophy treatment made by Sarepta Therapeutics — is also under FDA review. The agency deferred its decision on whether to approve the drug in late May after an advisory panel concluded the drug was not effective.
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