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FDA sets new date for panel review of Sarepta's muscle drug
March 10, 2016 / 6:25 PM / in 2 years

FDA sets new date for panel review of Sarepta's muscle drug

(Reuters) - An independent panel of experts to the U.S. Food and Drug Administration (FDA) will discuss Sarepta Therapeutics Inc’s muscle wasting drug on April 25, nearly three months after the original date.

The agency on Jan. 20 postponed the meeting evaluating the company's keenly watched Duchenne muscular dystrophy drug, eteplirsen, due to an inclement weather forecast for Washington DC. (1.usa.gov/24T8HOa)

FDA staff on Jan. 15 had said they were unconvinced about eteplirsen’s efficacy and trial design, a day after the regulator rejected Kyndrisa, a rival drug developed by BioMarin Pharmaceutical Inc.

Eteplirsen, like Kyndrisa, is designed to treat a subset of patients with DMD, which hampers muscle movement and affects one in 3,600 newborn boys, with most patients dying by the age of 30.

The regulator is expected to make its final decision on eteplirsen by May 26, Jefferies’ analysts wrote on Thursday.

There are no FDA-approved drugs for DMD, and pressure has been mounting on the agency to swiftly approve treatments.

Shares of Sarepta, which said on Tuesday it would slash about 17 percent of its workforce, were up 8.5 percent at $15.06.

BioMarin’s stock was down about 3 percent at $82.58.

Reporting by Natalie Grover in Bengaluru

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