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Intercept granted accelerated approval from FDA for PBC treatment
Intercept Pharmaceuticals late Friday announced that the FDA has granted accelerated approval to Ocaliva, or obeticholic acid, for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis, in combination with ursodeoxycholic in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Ocaliva is an agonist of the farnesoid X receptor, a nuclear receptor expressed in the liver and intestine and a regulator of bile acid, inflammatory, fibrotic and metabolic pathways. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase. An improvement in survival or disease-related symptoms has not been established, the company noted.. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, it added. Ocaliva is expected to be available to PBC patients in the U.S. within 7-10 days and will be distributed through a specialty pharmacy network