The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for obeticholic acid (Intercept) for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH).

The NDA submission includes data from the REGENERATE trial, a phase 3, double-blind, placebo-controlled study that evaluated the safety and efficacy of obeticholic acid in 2480 patients with liver fibrosis due to NASH (histological evidence of fibrosis stage 2 or stage 3). Results showed that treatment with obeticholic acid 25mg once daily led to fibrosis improvement (by ≥1 stage) with no worsening of NASH at 18 months (P=.0002 vs placebo).

A Prescription Drug User Fee Act (PDUFA) date of March 26, 2020 has been set by the FDA for the application. “If approved, [obeticholic acid] 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 US as soon as 2020,” said Mark Pruzanski, MD, President and Chief Executive Officer of Intercept.

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Obeticholic acid (Ocaliva) is currently approved for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

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