India's CDSCO Expert Committee Recommends Local Trial Waivers for Generic Lenacapavir as HIV PrEP
核心洞察
India's Subject Expert Committee recommended waiving local Phase III and bioequivalence trials for generic lenacapavir PrEP from Dr. Reddy's and Emcure Pharmaceuticals.
The waiver applies only to the HIV prevention (PrEP) indication, not to treatment of multidrug-resistant HIV-1 (搜索), which requires additional pharmacokinetic and ethnicity data.
Marketing authorization would be conditional on mandatory post-marketing Phase IV efficacy studies, with protocols due to CDSCO within three months.
India has moved closer to the availability of generic lenacapavir for HIV prevention after a Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (搜索) (CDSCO) recommended the waiver of local clinical trials for Dr. Reddy's Laboratories Limited and Emcure Pharmaceuticals Limited. The recommendation, made at the committee's 08th/26 meeting held on 11 August 2026 at CDSCO headquarters in New Delhi, could accelerate access in India, subject to final marketing authorisation and mandatory post-marketing Phase IV efficacy studies.
The recommendations concern lenacapavir injection 463.5 mg/1.5 mL for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 (搜索) in adults and adolescents weighing at least 35 kg who are at increased risk of acquiring HIV.
Committee Recommends Waivers for the PrEP Indication
Dr. Reddy's Laboratories and Emcure Pharmaceuticals sought waivers of local Phase III clinical trials and bioequivalence studies for their respective applications. The applications relied, among other material, on clinical evidence generated for the innovator product and regulatory approvals granted in the United States, European Union, United Kingdom, Australia and other jurisdictions.
The committee considered the data presented by the innovator and recognised that long-acting lenacapavir for HIV prevention addresses an unmet medical need in India. On this basis, the committee recommended waiver of the proposed local Phase III clinical trial and bioequivalence study requirements for the PrEP indication, subject to specified regulatory conditions. The individual must be HIV-1 (搜索) negative before lenacapavir is initiated.
Mandatory Phase IV Efficacy Study as a Condition of Authorisation
The committee recommended that the grant of marketing authorisation to both applicants be subject to a requirement to conduct post-marketing Phase IV studies in India, with efficacy as the primary endpoint, among individuals receiving lenacapavir for PrEP. Accordingly, upon grant of marketing authorisation, each company would be required to submit its Phase IV study protocol to CDSCO within three months. The protocols would then be placed before the committee for further evaluation.
Treatment Indication Waiver Not Recommended
On Emcure Pharmaceuticals' application for waiver, the committee did not recommend the same regulatory flexibility for the use of lenacapavir in heavily treatment-experienced people with multidrug-resistant HIV-1 (搜索) whose existing treatment regimen is failing. The committee noted that lack of adequate evidence related to pharmacokinetic and ethnicity did not support the requested waiver for the treatment indication.
The applicants would therefore need to address the evidentiary deficiencies identified by the committee and comply with any additional data or study requirements specified by CDSCO before the treatment indication could be authorised in India. The committee's recommendations therefore distinguish between two separate uses of lenacapavir: PrEP to prevent HIV-1 (搜索) acquisition in people without HIV, and treatment, in combination with other antiretrovirals, of heavily treatment-experienced people living with multidrug-resistant HIV-1.
A Major Advance in HIV Prevention
Lenacapavir is a first-in-class, long-acting HIV-1 capsid (搜索) inhibitor. Under the internationally approved PrEP regimen, initiation requires both oral lenacapavir tablets and subcutaneous injections. The subsequent maintenance dose is 927 mg every six months, administered as two subcutaneous injections of 463.5 mg/1.5 mL each. Availability of both the injectable and oral initiation components will therefore be necessary for implementation of the complete regimen.
In the international PURPOSE 1 trial, no HIV infections occurred among participants receiving lenacapavir at the primary analysis. In PURPOSE 2, lenacapavir reduced HIV incidence by 96% compared with estimated background incidence. These results established twice-yearly injectable lenacapavir as a highly effective new option for HIV prevention.
Long-acting PrEP could be particularly valuable for people who face difficulties taking a tablet every day because of adherence challenges, stigma, lack of privacy, mobility or limited access to healthcare services.
Potential to Accelerate Affordable Access in India
The committee's recommendations could substantially shorten the regulatory pathway for Indian manufacturers by avoiding duplicative local Phase III trials where substantial international efficacy and safety evidence already exists. Upon accepting the recommendations and grant of the necessary permissions, Dr. Reddy's Laboratories and Emcure Pharmaceuticals could become among the first Indian manufacturers authorised to supply generic lenacapavir for PrEP in India, subject to compliance with the stipulated conditions.
This is essential to bring lenacapavir within the reach of individuals and public health programmes. Indian manufacturers are already central to international efforts to make affordable generic lenacapavir available in low- and middle-income developing countries. The committee's recommendations therefore represent a significant step towards expanding access to long-acting HIV prevention in India. Nevertheless, timely final regulatory decisions, affordable pricing, adequate manufacturing capacity, inclusion in national HIV-prevention programmes, provider training and reliable HIV-testing systems will all be necessary to translate the regulatory pathway into meaningful access.