(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, the regulator can ask the company to withdraw it from the market.
The FDA had said in December the drug was being studied for any injury to the organ in patients without severe scarring, based on its review of post-market clinical trial data.
In 2021, the regulator had restricted the use of Ocaliva in patients with advanced cirrhosis or scarring of the liver.
The FDA has also placed a clinical hold on all Intercept clinical trials conducted in the U.S. involving obeticholic acid, the company said on Thursday.
Intercept added that it will provide additional information to healthcare professionals and patients as it works with the FDA on the transition process.
(Reporting by Sneha S K in Bengaluru; Editing by Shreya Biswas)
Comments