The Eteplirsen Precedent: No Denying It – So Let’s Define It

US FDA allowing Sarepta to seek accelerated approval for follow-on DMD agent – following 'precedent' set by eteplirsen. Now the new challenge is to define exactly what that precedent is.

It took almost 18 months to become clear, but it is now safe to say that the US FDA’s September 2016 approval of Sarepta Therapeutics Inc.’s eteplirsen for Duchenne Muscular Dystrophy is precedent-setting after all.

The circumstances surrounding that approval were obviously unprecedented from the first. The drug was approved because Center for Drug Evaluation...

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