CDSCO Panel Rejects Hetero Lab's Plea for Lenacapavir Approval Without Local Trials
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has declined the proposal submitted by Hetero Labs Limited, Hetero Corporate for Lenacapavir Tablets 300 mg. The company had sought permission to manufacture and market Lenacapavir 300 mg in India, along with a waiver of the Phase III clinical trial and a waiver of the bioequivalence (BE) study. However, after detailed evaluation, the committee rejected both requests.
Hetero Labs presented its proposal along with justification for waiving local Phase-III clinical trials and BE requirements. The committee was informed that the company had already received approval from the BA/BE division of CDSCO to conduct a BE study for export purposes, and this study is currently ongoing. The firm also submitted published global clinical trial data on Lenacapavir to support its request.
However, the SEC noted that the company did not present any clinical data for an Indian patient subset, which is essential to demonstrate the absence of substantial ethnic variability. Due to this, the committee found that there was insufficient efficacy and safety evidence to confirm whether the proposed 300 mg dosage would be appropriate for the Indian population.
The committee further recorded that the new drug Lenacapavir, in both tablet and injectable forms, is indicated for the management of heavily treatment-experienced adults with multi-drug resistant HIV-1 infection. Considering the drug’s critical therapeutic category and the need for population-specific safety evaluation, the SEC held that waiving local studies would not be scientifically justified.
After detailed deliberation, the SEC did not recommend granting BE waiver or local Phase-III clinical trial waiver, thereby requiring the firm to generate India-specific clinical data before any marketing authorisation can be considered.
