FDA declines to approve Intercept's fatty liver disease drug
FDA determined the marketing application for the drug cannot be approved in its present form
(Reuters) - The U.S. Food and Drug Administration declined to grant accelerated approval for Intercept Pharmaceuticals' drug to treat a type of fatty liver disease, sending its shares down more than 11% in extended trading.
The rejection marks Intercept's second failed attempt at securing approval for the drug to treat patients with non-alcoholic steatohepatitis (NASH) - a liver disease that affects 5% of U.S. adults but has no approved treatments after numerous clinical failures by several drugmakers.
Intercept was previously turned down by the FDA in 2020 as the agency determined the drug's predicted effectiveness failed to outweigh potential risks.
Following the FDA's decision on Thursday, the company said it has decided to discontinue all NASH-related investment and restructure its operations to strengthen focus on rare and serious liver diseases.
Intercept said the FDA determined the marketing application for the drug cannot be approved in its present form.
The FDA's decision was on expected lines. In May, its panel of advisers recommended holding off on accelerated approval for the oral drug till its late-stage study data becomes available.
Ahead of the May meeting, the health regulator's staff reviewers had flagged a string of safety concerns such as drug-induced liver injury and an increased risk of diabetes associated with the drug that already faces questions about its efficacy.
Analysts have since expected the company to stop its late-stage NASH trial and focus on maximizing its market share in treating primary biliary cholangitis (PBC), a chronic liver disease.
Several drugmakers including Novo Nordisk, Madrigal Pharmaceuticals and Akero Therapeutics are competing to bring the first treatment for NASH to the market.
