Conduct Phase III CT of Ursodeoxycholic acid for Non-alcoholic fatty liver disease: CDSCO Panael Tell Abbott

New Delhi: In response to the proposal presented by the drug major Abbott for the additional indication for the already marketed formulation UrsodeoxycholicAcid tablets for the treatment of Non-alcoholic fatty liver disease (NAFLD) with transaminitis, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct the Phase III clinical trial of the proposed drug for the proposed indication.

This came after the drug major Abbott presented its proposal for already marketed formulation UrsodeoxycholicAcid tablets IP 150mg/300mg/450mg/600mg for additional indication i.e. for the “treatment of Non-alcoholic fatty liver disease (NAFLD) with transaminitis” before the committee.

The committee noted that the applied indication is not approved anywhere in the world.

Non-alcoholic fatty liver disease (NAFLD) represents a spectrum of liver disease with key stages consisting of hepatic steatosis (NAFL), steatohepatitis (NASH), fibrosis, and eventual cirrhosis.

Ursodiol is in a class of medications called gallstone dissolution agents. It works by decreasing the production of cholesterol and by dissolving the cholesterol in bile to prevent stone formation and by decreasing toxic levels of bile acids that accumulate in primary biliary cirrhosis.

Ursodeoxycholic acid (ursodiol) is a naturally occurring hydrophilic bile acid demonstrated to decrease cholestasis. Ursodiol has been postulated to reduce the hydrophobic bile acids in the hepatobiliary system to lessen the potential for hepatotoxicity.

At the recent SEC meeting, Gastroenterology and Hepatology held on the 15th of February 2024, the expert panel reviewed the proposal already marketed formulation UrsodeoxycholicAcid tablets IP 150mg/300mg/450mg/600mg for additional indication i.e. for the “treatment of Non-alcoholic fatty liver disease (NAFLD) with transaminitis”.

After detailed deliberation, the committee opined for conducting the Phase III clinical trial for Ursodeoxycholic Acid tablets IP 150mg /300mg /450mg /600mg for applied indication.

In addition, the expert panel suggested the firm submit the Phase III clinical trial protocol to CDSCO for further review by the committee.

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