Dr Reddys, Emcure Lenacapavir Gets CDSCO Panel Nod for CT, BE Waivers in HIV PrEP
New Delhi: In a significant regulatory development that could expand access to long-acting HIV prevention in India, pharmaceutical majors Dr. Reddy's Laboratories Limited and Emcure Pharmaceuticals Limited have received a CDSCO nod from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) for clinical trial (CT) and bioequivalence (BE) study waivers for Lenacapavir Injection 463.5 mg/1.5 mL for use as pre-exposure prophylaxis (PrEP).
The expert panel agreed to the waivers after reviewing data presented by the companies from the innovator and recognising PrEP for reducing the risk of sexually acquired HIV-1 infection among at-risk adults and adolescents as an unmet medical need.
The recommendations were made during the SEC (Antimicrobial & Antiparasitic) meeting held on August 11, 2026, where the companies separately presented proposals seeking permission to manufacture and market Lenacapavir Injection in India.
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Dr. Reddy’s Laboratories presented its proposal seeking permission for the manufacture and marketing of Lenacapavir Injection 463.5 mg/1.5 mL (309 mg/mL), along with justification for the waiver of the Phase III clinical trial and BE study.
During its deliberations, the committee noted that lenacapavir has already received approval in several major international markets, including the United States, Canada, United Kingdom, European Union and Australia, besides a few other countries.
The committee subsequently reviewed the data presented by Dr. Reddy’s from the innovator.
After examining the available evidence, the SEC opined that pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at increased risk of HIV-1 acquisition represents an unmet medical need.
The committee further specified that individuals must have a negative HIV-1 test before initiating lenacapavir.
Considering the innovator data and the unmet medical need, the panel agreed to the BE and clinical trial waiver for Lenacapavir Injection 463.5 mg/1.5 mL proposed by Dr. Reddy’s.
The recommendation, however, comes with a post-marketing clinical study requirement.
The committee recommended,
"Conduct a Phase IV study with efficacy as the primary endpoint in persons needing PrEP. Accordingly, firm is required to submit Phase-IV study protocol to CDSCO within the period of three months of grant of Market Authorization for further evaluation by the committee."
Emcure Pharmaceuticals Limited also presented its proposal seeking permission to manufacture and market Lenacapavir Injection 463.5 mg/1.5 mL, along with justification for waiver of the Phase III clinical trial and BE study.
Similar to its deliberations on Dr. Reddy’s proposal, the committee noted that lenacapavir is already approved in the US, Canada, UK, EU, Australia and a few other countries.
However, Emcure's proposal involved regulatory consideration of lenacapavir not only for HIV prevention but also for its use in heavily treatment-experienced patients with multidrug-resistant HIV-1 infection.
For this treatment indication, the SEC raised concerns over the adequacy of the available evidence.
The committee specifically noted a lack of adequate evidence related to pharmacokinetics and ethnicity for the use of lenacapavir in heavily treatment-experienced patients with multidrug-resistant HIV-1 infection.
Consequently, the expert panel did not recommend the Phase III clinical trial waiver for the treatment indication.
The panel, however, reached a favorable conclusion when it separately evaluated the drug for pre-exposure prophylaxis (PrEP).
For the PrEP indication, the committee reviewed data presented by Emcure from the innovator and agreed that PrEP to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at increased risk of HIV-1 acquisition constitutes an unmet medical need.
Accordingly, the SEC agreed to the BE and clinical trial waiver for Lenacapavir Injection 463.5 mg/1.5 mL for the PrEP indication.
Similar to the condition imposed on Dr. Reddy’s, Emcure has been recommended to conduct a Phase IV study with efficacy as the primary endpoint in persons requiring PrEP and submit the study protocol to CDSCO within three months of the grant of Marketing Authorization.
The committee recommended conducting a Phase-IV study with efficacy as the primary endpoint in persons needing PrEP.
Accordingly, it states,
"The firm is required to submit a Phase-IV study protocol to CDSCO within the period of three months of grant of Market Authorization for further evaluation by the committee."
