Sarepta Drug Critic Departs FDA, Raising Hope for Approval

Updated from 6:26 am ET with new information.

Dr. Ronald Farkas was in charge of the clinical review team at the U.S. Food and Drug Administration which argued against the approval of eteplirsen, the Duchenne muscular dystrophy drug developed by Sarepta Therapeutics (SRPT) .

Last week, Farkas left the FDA for a new job in the private sector while the agency's eteplirsen review is still underway, the FDA confirmed Wednesday.

The departure of an important eteplirsen critic from the FDA could be a sign that the internal agency debate over Sarepta's drug is coming to an end, with officials advocating for approval getting their way.

Or, Farkas' exit from the FDA might not be related to the eteplirsen review at all, but is just another example of a government official deciding to make more money in the private sector.

Either way, speculation over Farkas' change in FDA employment status and what it means for eteplirsen is the latest twist in what feels like a review process that will never end.

Thirteen months have passed since Sarepta filed the new drug application with FDA seeking the approval of eteplirsen to treat patients with Duchenne, a rare and fatal neuromuscular wasting disease that primarily affects boys. In that time period, the FDA has convened an advisory panel meeting to debate the merits of eteplirsen's clinical data and asked Sarepta to provide additional information about the drug.

At this point, the FDA's eteplirsen review has dragged on almost twice as long as the review of similar drugs seeking approval for rare diseases.

Farkas could not be reached for comment, but he took a new job with Parexel, a clinical research organization and consulting firm working for biotech, pharmaceutical and medical device companies, according to the company.

As a team leader in the neurology division of the FDA, Farkas oversaw the clinical review of eteplirsen. In their review, Farkas and his team concluded the eteplirsen clinical data compiled by Sarepta was not strong enough to warrant the drug's approval. But not everyone at the FDA agreed with this negative assessment, which is why the agency's deliberations are still ongoing.

Sarepta shares rose 12% in Tuesday's after-market trading session after rumors of Farkas' departure were spread via Twitter. Before that, the stock closed Tuesday down 8%.

Shares of Sarepta are up 25% to $32 in Wednesday trading.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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