Intercept Pharmaceuticals Inc. won approval for a drug to treat an uncommon, slow-progressing liver disease called primary biliary cirrhosis, its first product to reach the U.S. market.
The Food and Drug Administration cleared Intercept’s Ocaliva, also known as obeticholic acid, according to a statement from the company on Friday. The agency approved the drug with the condition that Intercept perform further studies to show it reduces patients’ risk of liver transplant and death.