This came after Dr. Reddy’s Laboratory presented its proposal for a grant of permission for the manufacture and marketing of the drug Resmetirom Tablet 60/80/100 mg.
The firm has submitted the application along with the BE study protocol and the Phase III CT protocol. However, the firm did not present the Phase III protocol.
Dr. Reddy’s Laboratory presented only the BE study protocol titled “An open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, oral bioequivalence study of test product (T) Resmetirom Tablets 100 mg of Dr. Reddy’s Laboratories Limited, India, comparing with reference product (R) Rezdiffra (resmetirom) tablets 100 mg of Madrigal Pharmaceuticals, Inc., in normal, healthy, adult human subjects, under fasting condition” (Protocol No. 060-25, Version 01, dated 14 Apr 2025) for the drug Resmetirom Tablet 60/80/100 mg before the committee.
Resmetirom is a thyroid hormone receptor-beta agonist used to treat noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis in adults.
Resmetirom is a thyroid hormone receptor-beta (THR-beta) agonist. On March 14, 2024, it was approved by the FDA as the first treatment of liver fibrosis due to noncirrhotic non-alcoholic steatohepatitis (NASH), which is a form of non-alcoholic fatty liver disease (NAFLD).
Thyroid hormones directly regulate lipid metabolism in the liver; thus, impaired thyroid function, such as low serum thyroid hormone levels, is often observed in NAFLD. Resmetirom works to reduce liver fat by stimulating fatty acid degradation and oxidation.
After detailed deliberation, the committee recommended the grant of permission to conduct the BE study per the protocol presented.
Accordingly, the expert panel suggested that the firm should submit the BE study report to CDSCO for further review by the committee.
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