The PDUFA date for FDA review of Ocaliva to treat NASH is extended to 26 June 2020.- Intercept Pharma
Related news and insights
NGM Biopharmaceuticals, Inc. reported results from the 24-week Phase IIb ALPINE 2/3 study evaluating aldafermin in 171 patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) with stage 2 or 3 liver fibrosis (F2/F3).
Inventiva announced the details of the Phase III clinical trial with its lead drug candidate lanifibranor in NASH following the end-of-phase II meeting with the FDA and the receipt of the Scientific Advice letter from the European Medicines Agency (EMA).
Intercept Pharmaceuticals announced multiple new analyses supporting the use of routine noninvasive tests (NITs) to identify patients with advanced fibrosis due to NASH and measure Ocaliva (obeticholic acid or OCA) treatment response.