By Christiana Sciaudone
Investing.com -- Intercept Pharmaceuticals shares (NASDAQ:ICPT) tumbled 39%, to their lowest in seven years on Monday after the U.S. Food and Drug Administration said the benefits of its new liver disease drug are uncertain and don’t outweigh potential risks.
The FDA’s Complete Response Letter regarding Intercept’s new drug application for obeticholic acid (OCA) for the treatment of fibrosis due to nonalcoholic steatohepatitis requested additional post-interim analysis efficacy and safety data in support of potential accelerated approval.
“At no point during the review did the FDA communicate that OCA was not approvable on an accelerated basis, and we strongly believe that the totality of data submitted to date both meet the requirements of the Agency’s own guidance and clearly support the positive benefit-risk profile of OCA,” said Mark Pruzanski, the head of Intercept. “We are disappointed to see the determination the Agency has reached based on an apparently incomplete review, and without having provided medical experts and patients the opportunity to be heard at the anticipated Adcom on the merits of OCA.”
Intercept said it plans to meet with the FDA to discuss the letter and “discuss options for an efficient path forward to approval."