Now that Sarepta has bolted out of the barn, the FDA wants to shut the door
Now that the FDA has capped Sarepta’s long and controversial campaign to win an approval for its Duchenne muscular dystrophy drug with an accelerated approval, FDA officials would like to send a very clear message to any other biotech looking to slug their way forward using the same tactics: Forget about it.
In a presentation at a summit meeting of the National Organization of Rare Diseases on Tuesday, John Jenkins, director of the office of new drugs at the Center for Drug Evaluation and Research, singled out the eteplirsen case as a new textbook example of what other companies should avoid.
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