CEO resignation linked to FDA drug approval process

April 2, 2015

Sarepta Therapeutics CEO Chris Garabedian resigned earlier this week, a move that may be linked to a dispute with the Food and Drug Administration (FDA) over the approval process for its new drug, according to The Wall Street Journal.

Sarepta Therapeutics CEO Chris Garabedian resigned earlier this week, a move that may be linked to a dispute with FDA over the approval process for its new drug, according to The Wall Street Journal.

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Sarepta appeared to have angered FDA with a press release about the approval process for the drug it is developing to treat Duchenne muscular dystrophy, a genetic disorder. Garabedian was temporarily replaced by Ed Kaye, chief medical officer for the company.

Last fall, Sarepta released a statement saying FDA may delay approval of its new drug because of irregularities with trial data. FDA issued its own statement to clarify its intent, after parents and investors expressed concerns.

Some analysts viewed the Sarepta release as a way to pressure the agency not to delay approval of its drug, WSJreported.

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However, Sarepta executives said FDA approval of its drug is still on course. “It’s really about going in a different direction… to ensure we have the best opportunity with the FDA” to receive approval, interim chairman John Hodgson said during a call with investors, according to WSJ.

In addition, Sarepta is going ahead with its drug approval process. “This ship is going in the same direction, just with a different captain,” Kaye said during the call.

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