September 19, 2016
Sarepta Wins FDA Nod For Embattled DMD Drug -- But With A Catch
Arlene Weintraub
finance.yahoo.com
Just five days after its main nemesis at the FDA departed the agency, Sarepta Therapeutics has won a long-sought-after approval for eteplirsen, its drug to treat Duchenne muscular dystrophy (DMD). It’s been a long, strange trip for the Cambridge, MA-based company, which has held strong support from the DMD community but endured everything from a freak snowstorm that delayed an FDA advisory committee review, to the aforementioned critic, Ron Farkas, who seemed to be doing everything in his power to prevent eteplirsen from getting approved. In a statement, the FDA said it is requiring Sarepta to perform another clinical trial to prove the drug does what the company claims—namely that it improves motor function in DMD patients who have a particular mutation in a gene that produces dystrophin, a protein key in proper muscle function.
http://finance.yahoo.com/m/4abc677a-b9c1-33ef-8eb8-9dbd14042c9f/ss_sarepta-wins-fda-nod-for.html
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