(Reuters) – Intercept Pharmaceuticals’ liver disease drug is being observed for injury to the organ in patients without severe scarring, the U.S. Food and Drug Administration said on Thursday, based on its review of post-market clinical trial data.
The regulator had restricted the use of the drug, Ocaliva, in patients with advanced cirrhosis or scarring of the liver in 2021.
The FDA said on Thursday it has identified cases of serious liver injury among patients being treated for primary biliary cholangitis, a rare disease that causes inflammation of small bile ducts in the liver and can eventually destroy them.
Discontinue Ocaliva treatment with any evidence of liver disease progression or if efficacy is not established, the regulator recommended health care professionals.
This is another setback to the company after the regulator did not convert its accelerated nod for Ocaliva into a full approval last month.
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, the regulator could ask the company to withdraw it from the market.
(Reporting by Puyaan Singh in Bengaluru; Editing by Shilpi Majumdar)
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