FDA issues complete response letter for obeticholic acid for fibrosis due to NASH

The FDA issued a complete response letter for the new drug application for obeticholic acid for treatment of fibrosis due to nonalcoholic steatohepatitis, according to a press release from Intercept Pharmaceutical Inc.“Today represents a setback first and foremost for NASH patients with advanced fibrosis who have bene waiting far too long for a therapy to treat their disease,” Mark Pruzanski, MD, president and CEO of Intercept, said during a conference call. “It has been an extraordinarily challenging program to get to this point and we believe that we have convincing dataRead More