Approval may be around the corner for Sarepta Therapeutics' Duchenne muscular dystrophy drug Eteplirsen since its biggest critic, Ronald Farkas, MD, PhD, left his role at the Food and Drug Administration, according to CNBC.
Dr. Farkas, who was head of the FDA's clinical team in the neurology products division, played a large role in the FDA's review of Eteplirsen. During an FDA advisory meeting in April, Dr. Farkas said he had "strong doubts" about the reliability of Sarepta's clinical trial data and the drug's effectiveness, reported STAT.
The FDA deferred its decision on whether to approve the drug in late May after an advisory panel concluded the drug was not effective.
It is not clear when Dr. Farkas left the agency or whether his departure is tied to Sarepta.
"We view [his departure] as a positive signal for Eteplirsen approval," said Wall Street analyst Michelle Gilson. Cambridge, Mass.-based Sarepta's shares jumped about 26 percent to $32.45 upon news of Dr. Farkas' FDA exit.
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