Shares of Intercept Pharmaceuticals are dropping after the FDA postponed the advisory committee meeting relating to its new drug application for obeticholic acid for the treatment of liver fibrosis due to nonalcoholic steatohepatitis that was tentatively scheduled June 9. The postponement will accommodate the review of additional data requested by the FDA that the company intends to submit within the next week, Intercept said in a statement. The FDA has indicated that it will reach out to Intercept in the near future with a new proposed AdCom date, it added. Intercept now anticipates that the FDA’s review of its NDA will extend beyond the Prescription Drug User Fee Act target action date of June 26. “While this delay was unanticipated, following our most recent dialogue with the FDA we believe that the additional data being submitted will be important in facilitating a more informed discussion at the AdCom,” said Mark Pruzanski, CEO Intercept. “We remain confident in our NDA submission and look forward to continuing to work with the FDA to bring the first treatment to patients with advanced fibrosis due to NASH.” Shares of Intercept are down 11% to $82.00 in premarket trading.
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