Sarepta Therapeutics Inc (NASDAQ:SRPT) has received additional support from over 36 doctors who have written a letter to U.S. FDA, asking it to approve company’s experimental therapy eteplirsen. Sarepta has been facing a lot of challenges, especially in the case of eteplirsen. The decision of doctors supporting the approval of eteplirsen has come as a morale booster for Sarepta Therapeutics.
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FDA advisory committee is likely to meet on April 25, 2016, to discuss the future of eteplirsen. Sarepta isn’t sure about what FDA will come up with; however, it’s confident about the change that eteplirsen can bring. It’s not the first time when FDA has received so many applications supporting a DMD drug. Last month, over 109 Congress members sent their letters to FDA to accelerate the approval process of FDA drugs.
The news of 36 best Duchenne Muscular Dystrophy or DMD doctors showing open support for eteplirsen worked well for the company in the stock market. As soon as this news was published, Sarepta’s shares went up by 16% on Monday. As per the reports, the letter was written on February 24, 2016, to FDA’s Neurology Director, Billy Dunn. He’s the person-in-charge for the clinical review of eteplirsen.
According to the medical experts, the best way to take Duchenne community to newer heights is to speed up the approval process, followed by a confirmatory trial to make sure it can be commercially deployed without any hassle. The medical review of eteplirsen was first released in January; however, the experience wasn’t very good for Sarepta. FDA staff criticized the drug, which sent a wrong image in the market. The support from different communities that started pouring in from that time hasn’t stopped yet.
FDA has extended the review period of eteplirsen to May; hence, it will take another few months to get a clear idea whether eteplirsen makes it to the market commercially or not.