Thomas Capozza News Today

Intercept Pharmaceuticals saw a 16% drop in its stock value after an FDA advisory committee declined to approve obeticholic acid in pre-cirrhotic patients with liver fibrosis due to nonalcoholic steatohepatitis. The vote before the Gastrointestinal Drug Advisory Committee on May 19 was Intercept’s second bid to put its 25 mg obeticholic acid product (Ocaliva) in a lead position as the first

An FDA advisory committee voted against approval for obeticholic acid in pre-cirrhotic patients with liver fibrosis due to nonalcoholic steatohepatitis, citing “concerning” risk/benefit profile.

Data from Phase 3 REGENERATE study supporting positive benefit-risk profile of obeticholic acid in liver fibrosis due to NASH to be featured in late-breaker podium presentation Analysis... | October 31, 2022