FDA looks likely to cut off Intercept's latest NASH bid

The US Food and Drug Administration’s (FDA) Gastrointestinal Drugs Advisory Committee does not appear to sold on Intercept Pharmaceuticals’ (Nasdaq: ICPT) obeticholic acid (OCA) in pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis (NASH).

Members of the committee expressed safety concerns and voted against approving OCA based on current data during Friday’s meeting, in what is the latest setback for the Intercept NASH hopeful. The US company’s push for an accelerated approval was first rejected by the FDA in 2020 after multiple delays. The drug is marketed as Ocaliva in primary biliary cholangitis.

On Friday, 12 of 16 voting-eligible committee members voted “no,” with two abstentions, on the voting question of whether, given the available efficacy and safety data, the benefits of OCA 25mg outweigh the risks in NASH patients with stage two or three fibrosis.