(Reuters) – Intercept Pharmaceuticals said on Thursday it is withdrawing its liver disease drug from the U.S. market following a request from the Food and Drug Administration.

This comes as another setback for the company after the U.S. FDA last year declined full approval for the drug, Ocaliva, and said it had identified cases of liver injury in patients who were on it.

Ocaliva, chemically known as obeticholic acid, got the FDA’s accelerated approval in 2016 to treat patients with primary biliary cholangitis, a rare disease that causes inflammation of small bile ducts in the liver and can eventually destroy them.

Under the accelerated pathway, the FDA mandates additional post-market trials that verify the drug’s benefits. If data from the trials do not show the drug’s effectiveness, th

See Full Page