Mankind Pharma gets CDSCO Panel nod for bioequivalence study of Resmetirom Tablets

New Delhi: Rejecting the Phase III clinical trial waiver for Resmetirom tablets 60 mg, 80 mg, and 100 mg, proposed by Mankind Pharma, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to conduct a bioequivalence (BE) study as per the protocol presented by the firm.

Furthermore, the expert panel stated that the firm is required to submit published clinical data, preferably in Indian and Southeast Asian populations, along with a BE study report for further review by the committee.

This came after the firm presented the proposal for grant of permission for manufacturing and marketing of Resmetirom Tablets 60 mg, 80 mg, and 100 mg, along with the protocol for the BE study and justification for the Phase III clinical trial waiver, before the committee.

Resmetirom is a thyroid hormone receptor beta (THR-β) agonist used in conjunction with diet and exercise in the therapy of nonalcoholic steatohepatitis (NASH) with moderate-to-severe fibrosis.

Resmetirom is an orally active, liver-directed selective thyroid hormone receptor-β agonist, targeting key metabolic pathways involved in hepatic lipid metabolism and inflammation. It is highly selective, with 28 times greater selectivity for THR-β versus THR-α than triiodothyronine.

Resmetirom is a medication approved by the FDA to treat adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis, working by targeting thyroid hormone receptor beta (THR-β) in the liver to reduce fat and improve liver health.

At the recent SEC meeting on gastroenterology and hepatology held on February 27th, 2025, the expert panel reviewed the proposal for grant of permission for manufacturing and marketing of Resmetirom tablets 60 mg, 80 mg, and 100 mg, along with the protocol for the BE study and justification for the Phase III clinical trial waiver.

After detailed deliberation, the committee recommended the grant of permission to conduct the BE study as per the protocol presented by the firm.

Further, the committee did not recommend a Phase III CT waiver at this stage. In addition, the expert panel suggested that the firm is required to submit published clinical data, preferably in Indian and Southeast Asian populations, along with a BE study report for further review by the committee.

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