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FDA gives preliminary OK to drug aimed at Duchenne muscular dystrophy
September 19, 2016 3:07 PM
Today, the Food and Drug Administration preliminarily approved eteplirsen, making the drug available to other Duchenne sufferers who have been waiting for years as the FDA missed decision deadlines and required more and more data from manufacturer Sarepta Therapeutics in Massachusetts.
The action makes eteplirsen the first drug approved to treat muscular dystrophy.
Approval came under an accelerated process for “orphan drugs” prescribed for rare diseases for which there are no other treatments. Because the drug was fast tracked, confirmatory studies are required before it can be given full approval.
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