Intercept pivots away from NASH following second FDA rejection for obeticholic acid

Key takeaways:The FDA issued a complete response letter to Intercept indicating it cannot approve the company’s new drug application for obeticholic acid as a treatment for pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis.Following an unfavorable vote before the FDA’s Gastrointestinal Drug Advisory Committee in May, the agency’s rejection of obeticholic acid (Ocaliva, Intercept Pharmaceuticals) was not unexpected. In its letter, the FDA emphasized that any resubmission of obeticholic acid (OCA) for NASH would require at least successful completion ofRead More