FDA approves Intercept's Ocaliva for PBC

FDA granted accelerated approval to Ocaliva obeticholic acid from Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) to treat primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in patients with inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.

Intercept expects to launch Ocaliva in the U.S. within seven to 10 days, with an annual price of $69,350. Ocaliva is under EMA review to treat PBC, and is in Phase III testing to treat non-alcoholic steatohepatitis (NASH). ...