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  • Conduct Phase III CT...

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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-03-10T18:00:49+05:30  |  Updated On 21 March 2024 9:19 PM IST
CDSCO Panel Clears Abbotts Phase IV Trial for Empagliflozin + Metformin FDC, Seeks More Sites
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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.

Also Read: Eli Lilly gets CDSCO Panel Nod to Import, Market Antidiabetic Drug Tirzepatide solution for injection Single dose vial

Abbottcdscoursodeoxycholic acidnonalcoholic fatty liver disease
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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