Sarepta Therapeutics Inc (NASDAQ:SRPT) announced that FDA had allotted another date for the panel review of its muscle drug. As per the reports, an independent group of experts will hold a meeting on April 25, 2016, to discuss Sarepta’s muscle wasting drug.
Earlier, Sarepta’s Duchenne muscular dystrophy drug named eteplirsen was scheduled to be reviewed on January 20, 2016; however, FDA postponed this meeting due to the inclement weather forecast in Washington state.
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On January 15, 2016, FDA staff had indicated that eteplirsen wasn’t good enough in terms of trial design and efficiency, and that the company needed to make some improvements to get the drug to market.
The announcement was made a day after the rejection of Kyndrisa by FDA. Kyndrisa is a rival drug, which is developed and marketed by BioMarin Pharmaceutical Inc. Most of the functions of these two drugs are not different as they are designed to treat patients suffering from DMD that hampers muscle movements badly. Reports claim that one in every 3600 newborn babies are affected by this disease, and most patients die even before they turn 30.
In a recent statement, Jefferies’ analysts cited that FDA is expected to take the final call on eteplirsen latest by May 26, 2016. So far FDA hasn’t any drug containing DMD, which has created extra pressure on the agency to approve the treatments as soon as possible.
After announcing that it would cut 17% jobs in the near future, shares of Sarepta were expected to plunge into the market; however, as soon as this update was announced, it witnessed 8.5% hike in the share prices. Going forward, it will continue to come up with more and more such drugs that can treat people suffering from diseases that need unmet medical attention. More details about these announcements will be made public at a later date.
