All articles tagged with #intercept pharmaceuticals
The FDA advisory panel's negative vote on Intercept Pharmaceuticals' drug obeticholic acid seems to end hopes for FDA-approved drugs to treat NASH, a liver condition. However, other drugs are still in the pipeline for approval.
Trading of Intercept Pharmaceuticals' common stock has been halted as the FDA's Gastrointestinal Drugs Advisory Committee reviews obeticholic acid as a treatment for pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 22, 2023, for the review of the New Drug Application (NDA) for obeticholic acid. Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases.
The US FDA staff has raised concerns about the safety risks of Intercept Pharmaceuticals' treatment for nonalcoholic steatohepatitis (NASH), called obeticholic acid (OCA), citing increased risk of diabetes and liver injury. The FDA's outside advisers are set to discuss the drug on Friday. The drug was expected to become the first approved NASH therapy, but the FDA rejected the company's marketing application in 2020 due to potential risks. The total patient population eligible for OCA, if approved, will be between 6 million and 8 million Americans.