The PDUFA date for FDA review of Ocaliva to treat NASH is extended to 26 June 2020.- Intercept Pharma

Intercept Pharmaceuticals has stated it could take up to three months longer for regulators to make an approval decision on obeticholic acid (Ocaliva). The approval deadline is now set for 26 June 2020 rather than 26 March 2020. Intercept expected such a delay due to the scheduling of an upcoming FDA meeting. Set for 22 April 2020, the meeting will have a panel of independent experts evaluate obeticholic acid as a treatment for the disease, and then recommend to the FDA whether its safety and efficacy support approval. Given the timing, it was fairly certain an approval decision would be pushed back until after the panel makes its recommendation.