CDSCO Panel Rejects Hetero Lab's Plea for Lenacapavir Approval Without Local Trials

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.