Intercept Pharma's Ocaliva Gets FDA Accelerated Approval For Patients With PBC

(RTTNews) - Intercept Pharmaceuticals, Inc. (ICPT), a biopharmaceutical company focused on non-viral, progressive liver diseases, announced late Friday that the U.S. Food and Drug Administration or FDA has granted accelerated approval to Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis or PBC.

The company noted that Ocaliva is the first new medicine for PBC in nearly 20 years.

FDA has approved Ocaliva for treating PBC, previously known as primary biliary cirrhosis, in combination with ursodeoxycholic (UDCA) 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 (FXR), a nuclear receptor expressed in the liver and intestine and a key 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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.