Ocaliva for NASH Gets Thumbs Down From FDA Advisors
A panel of FDA’s outside experts said obeticholic acid (Ocaliva) does not have a favorable risk-benefit profile for treating nonalcoholic steatohepatitis (NASH) with pre-cirrhotic liver fibrosis, and recommended against accelerated approval of the drug. On Friday, the Gastrointestinal Drugs Advisory Committee voted 12-2 (with two abstentions) that the improvements in liver scarring seen in the […]
NASH Drug Candidate Comes With ‘Serious Risks,’ Says FDA Staff
While citing obeticholic acid’s (Ocaliva) modest effect on a single surrogate endpoint for nonalcoholic steatohepatitis (NASH), FDA staff members raised “substantial concerns” over the frequency of drug-induced liver injury, along with a litany of other safety concerns. The assessment dims the prospect of regulatory approval as the oral drug makes an iffy second bid to […]