Seemingly overnight, the Food and Drug Administration appears to be taking a more risk-averse stance on drug reviews, leaving drug makers confused and their stock prices battered.
Acadia Pharmaceuticals said Monday evening that it was notified by the FDA about “deficiencies” in its application for an expanded use for its anti-psychosis drug Nuplazid. The company said the letter from the agency arrived on March 3 without any warning, exactly one month before Acadia was expecting a decision on Nuplazid’s approval.
One week ago, Fibrogen said it received its own surprise FDA notice. The agency is convening an advisory panel meeting to review data on the company’s anemia pill, instead of rendering an approval decision by the March 20 deadline.
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