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July 30, 2014
09:04 EDTRNA, SRPTFDA says 'willing to explore' accelerated approval for DMD drugs
In response to a White House petition urging the FDA to accelerate approval for safe, effective therapies for children with Duchenne, Janet Woodcock, Director, FDA Center for Drug Evaluation and Research, said in a response, "We are willing to explore the use of all potential pathways for the approval of drugs for Duchenne muscular dystrophy, including accelerated approval, as appropriate." She added, "We share your sense of urgency to make safe and effective drugs available for patients with Duchenne muscular dystrophy as soon as possible. That's why we're actively engaged with a number of drug companies focused on developing new drugs for Duchenne muscular dystrophy, including Sarepta Therapeutics, the company developing eteplirsen, an investigational new drug for Duchenne muscular dystrophy." Shares of Sarepta (SRPT) are trading up 5%, or 97c, to $21.30 in pre-market trading. Yesterday afternoon, Wall Street Journal reported that Sarepta is limiting the role its CEO Chris Garabedian is playing in talks with the FDA. Prosensa (RNA) is also developing a treatment for Duchenne muscular dystroph, or DMD. Reference Link
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