Intercept Withdraws Ocaliva from Market After FDA Raises Safety Concerns

Intercept Pharmaceuticals has voluntarily withdrawn Ocaliva (obeticholic acid) from the U.S. market. Ocaliva is approved to treat patients with primary biliary cholangitis (PBC), a rare, progressive liver disease.

PBC is a progressive autoimmune disease that results from the destruction of the bile ducts in the liver. This leads to inflammation, scarring, and cirrhosis. The disease affects mostly women.

This decision follows a request from the FDA. In addition, the FDA has placed a clinical hold on all Intercept clinical trials involving obeticholic acid. Regulators said they had identified cases of serious liver injury among some trial participants who did not have a history of cirrhosis.

“While our view of Ocaliva’s benefit-risk profile differs from the FDA’s, we respect its request a