FDA accepts NDA for Ocaliva for the treatment of NASH

The FDA accepted the first new drug application for the treatment of liver fibrosis due to nonalcoholic steatohepatitis; Intercept announced that Ocaliva, already approved for the treatment of primary biliary cholangitis, has a PDUFA date of March 26, 2020.“If approved, OCA would be the first available therapy for patients with fibrosis due to NASH, a condition that is expected to become the leading cause of liver transplant in the U.S. as soon as 2020,” Mark Pruzanski, MD, president and CEO of Intercept, said in a press release issued by the manufacturer. “It is exciting toRead More

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