In a recent public statement, Sarepta Therapeutics Inc (NASDAQ:SRPT) announced that U.S. Food & Drug Administration’s PCNS (Peripheral and Central Nervous System) had rescheduled the panel meeting to review eteplirsen. As per the reports, now the review meeting will take place on April 25, 2016 in place of previously scheduled January 22, 2016.
Eteplirsen is the lead pipeline candidate that Sarepta has been working on for months.
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It’s not the lack of preparations of Sarepta that prompted FDA to postpone the review, but inclement weather conditions in the city. As soon as the news was announced, Sarepta’s shares gained more than 5.7% in intraday trading.
Sarepta is trying hard to get eteplirsen FDA approved as soon as possible, so that it can start the commercial deployment of the product for the treatment of those patients who are suffering from Duchenne muscular dystrophy.
FDA had first raised concerns against eteplirsen right before the January meeting of PCNS review panel. The doubts were unveiled in the briefing documents issued by the authority. In addition to this, a significant amendment submitted by Sarepta played a vital role in FDA’s approach towards reviewing this drug. So far, FDA has granted orphan drug and Fast Track status to eteplirsen.
DMD is one of the most dangerous health issues that affect one in every 3500-5000 newborn boys across the globe. As per the reports published by the company, eteplirsen can treat 13% of total patients affected by DMD. How investors react to this news will primarily depend on the outcome of the upcoming review meeting.
The senior management team of Sarepta hopes that things will fall in line and eteplirsen will get green signal from PCNS review panel in the upcoming meeting. It will keep all the investors informed about the outcome of this meeting via different communication channels.