FDA sets new date for
panel review of Sarepta's muscle drug
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[March 11, 2016]
(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.
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
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.
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BioMarin's stock was down about 3 percent at $82.58.
(Reporting by Natalie Grover in Bengaluru)
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