US FDA staff questions confirmatory trial data for Intercept's liver disease drug
Written By : MD Bureau Team
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-09-13 09:44 GMT | Update On 2024-09-13 09:44 GMT
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London: Staff reviewers at the U.S. Food and Drug Administration said on Wednesday a confirmatory trial did not show the effectiveness of Intercept's liver disease drug, which received the health regulator's accelerated nod in 2016.
Under the accelerated pathway, companies are required to conduct additional trials to establish their drug's benefits. Failure to do so can sometimes lead to market withdrawal.
Intercept's oral drug, Ocaliva, had been approved under the accelerated approval pathway to treat patients with primary biliary cholangitis (PBC), a rare disease that causes inflammation of small bile ducts in the liver and can eventually destroy them.
In 2021, FDA restricted use of Ocaliva to PBC patients who did not have advanced cirrhosis or severe scarring of the liver.
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