European regulators are locking the door on Sarepta’s Duchenne drug — but they aren’t throwing away the key
Sarepta Therapeutics $SRPT won’t be selling its Duchenne muscular dystrophy drug eteplirsen in Europe anytime soon.
European regulators at the CHMP confirmed their thumbs-down on the drug, Sarepta CEO Doug Ingram said, resisting the biotech’s attempt to change their position and setting up an all-but-certain formal rejection by the EMA.
Eteplirsen — sold in the US as Exondys51 — remains a highly controversial drug. Approved almost solely on the insistence of Janet Woodcock, who overrode objections from the review team and senior FDA officials, the drug’s label includes the note that the company has yet to prove its efficacy.
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