CDSCO Panel Rejects Phase III Trial Waivers for Resmetirom in India, Approves Bioequivalence Studies
核心洞察
India's CDSCO (搜索) expert committee has rejected Phase III clinical trial waivers for Resmetirom tablets proposed by both Morepen Laboratories (搜索) and Mankind Pharma, requiring local clinical data before marketing approval.
Resmetirom, a thyroid hormone receptor-β agonist recently approved for treating noncirrhotic NASH (搜索) with moderate to advanced liver fibrosis (搜索), works by regulating lipid metabolism and reducing liver fat.
The regulatory panel has granted permission for bioequivalence studies to proceed while requesting additional clinical data, particularly from Indian and Southeast Asian populations.
India's drug regulatory expert committee has rejected proposals from two pharmaceutical companies seeking to waive local Phase III clinical trials for Resmetirom, a novel treatment for non-alcoholic steatohepatitis (搜索) (NASH (搜索)), while approving bioequivalence studies for the medication.
The Subject Expert Committee (SEC) functioning under the Central Drug Standard Control Organisation (CDSCO (搜索)) reviewed separate applications from Morepen Laboratories (搜索) and Mankind Pharma at recent meetings held in March and February 2025, respectively.
Regulatory Decisions on Resmetirom
At the Gastroenterology and Hepatology SEC meeting on March 17, 2025, Morepen Laboratories (搜索) presented its proposal for manufacturing and marketing Resmetirom tablets (60 mg, 80 mg, and 100 mg), along with a bioequivalence study protocol and justification for waiving local Phase III clinical trials.
Similarly, Mankind Pharma had presented a comparable proposal at the SEC meeting held on February 27, 2025.
In both cases, the committee granted permission to conduct bioequivalence studies according to the protocols presented but rejected the requests for Phase III clinical trial waivers. For Mankind Pharma specifically, the committee additionally requested "published clinical data, preferably in Indian and Southeast Asian populations," to be submitted along with the bioequivalence study report for further review.
Understanding Resmetirom
Resmetirom represents a new class of medications known as thyroid hormone receptor beta (搜索) (THR-β (搜索)) agonists. The drug works by selectively targeting THR-β receptors in the liver, helping to regulate lipid metabolism and reduce hepatic fat accumulation.
The medication is highly selective, with 28 times greater selectivity for THR-β (搜索) versus THR-α compared to triiodothyronine, which helps minimize unwanted systemic effects while maximizing therapeutic impact on the liver.
Resmetirom is indicated for adult patients with noncirrhotic NASH (搜索) who have moderate to advanced liver fibrosis (搜索). It is designed to be used in conjunction with dietary modifications and exercise.
Clinical Significance for NASH Treatment
NASH (搜索) represents a significant health burden globally, characterized by liver inflammation and damage caused by fat accumulation in the liver. The condition can progress to advanced fibrosis, cirrhosis, and liver failure if left untreated.
Current treatment options for NASH (搜索) are limited, making new therapeutic approaches like Resmetirom particularly important. The drug's mechanism of action directly addresses the pathophysiology of NASH by reducing liver fat and improving metabolic parameters.
Regulatory Pathway Forward
The CDSCO (搜索) panel's decisions highlight India's regulatory emphasis on ensuring that new medications demonstrate safety and efficacy specifically in local populations before receiving marketing approval.
For both Morepen Laboratories (搜索) and Mankind Pharma, the path forward involves:
- Conducting the approved bioequivalence studies
- Developing and submitting Phase III clinical trial protocols for CDSCO review
- In Mankind's case, gathering published clinical data from Indian or Southeast Asian populations
These requirements reflect the regulatory authority's commitment to ensuring that medications approved for the Indian market have been adequately tested in populations that represent the intended patient base.
Implications for Patients and Healthcare Providers
While the regulatory process continues, Indian patients with NASH (搜索) will need to wait longer for access to Resmetirom. The drug represents a promising addition to the limited arsenal of treatments for this condition, which is growing in prevalence alongside rising rates of obesity and metabolic syndrome.
Healthcare providers treating NASH (搜索) patients in India will be watching the development of these clinical trials with interest, as positive results could eventually provide them with an important new therapeutic option for managing this challenging liver condition.