(Reuters) -Sarepta Therapeutics Inc said the U.S. drug regulator deferred an accelerated approval decision for its gene therapy for a muscle wasting disorder to June 22 from May 29, sending its shares tumbling 16% before the bell.
The U.S. Food and Drug Administration said it needs more time to complete the review of SRP-9001.The deferral followed a meeting of the regulator’s external advisers less than two weeks ago, where the panel narrowly backed an accelerated approval for the Duchenne muscular dystrophy therapy with 8-6 votes.
The regulator, however, indicated that it could potentially grant an accelerated approval for SRP-9001, initially for use in Duchenne patients aged 4 and 5. The drug was tested in DMD patients who could walk and were of the age 4-7 years.
DMD is a muscle-wasting disorder that is estimated to affect 1-in-3,500 male births worldwide, according to the National Organization for Rare Disorders.
(Reporting by Aditya Samal and Leroy Leo in Bengaluru; Editing by Shinjini Ganguli)
