Sarepta Therapeutics Inc (NASDAQ:SRPT), better known for its world-class RNA-targeted therapeutics, announced that FDA’s PCNS (Peripheral and Central Nervous System) Drugs Advisory Committee has agreed to review eteplirsen. As per the reports, PCNS will take a look at the New Drug Application of Sarepta on April 25, 2016.
The PDUFA (Prescription Drug User Fee Act) action date for completion of FDA review, is May 26, 2016.
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The U.S. Food And Drug Administration has already announced eteplirsen Priority Review status to execute things in a hassle-free manner. This status is designed for those drugs that provide treatment for diseases that can’t be cured with the help of any adequate therapy. Moreover, FDA also granted Fast Track Status, Orphan Drug Designation and Rare Pediatric Disease Designation to Sarepta’s eteplirsen drug.
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Before this update, Sarepta announced long-term plans to consolidate its facilities in Massachusetts. In order to increase operational efficiency, it seeks to move all of its operations to Massachusetts, where different teams can work together and take the company to all new heights. As of now its facility located in Corvallis, Oregon, focus on research manufacturing. Over the next few years, Sarepta plans to shift these operations to Massachusetts.
Company’s Chief Medical Officer and Interim CEO Edward Kaye says that it’s crucial for a company like Sarepta to focus on manufacturing, R&D, and commercialization of eteplirsen. Unless all the facilities are centralized, it can’t be possible, which is why the company has decided to bring all the key operations at one place.
Going forward, it will take many more such steps to improve operational efficiency in the best possible manner.