New Delhi: Generic variations of lenacapavir, a twice-yearly injectable drug that may stop Human Immunodeficiency Virus (HIV) an infection, have moved a step nearer to turning into out there in India after an knowledgeable panel below the nation’s drug regulator beneficial waiving native Section 3 medical trials for 2 Indian producers.
The Topic Knowledgeable Committee (SEC) on Antimicrobial & Antiparasitic Medicine, below the Central Medicine Commonplace Management Organisation (CDSCO), beneficial the waiver for functions from Dr Reddy’s Laboratories and Emcure Prescribed drugs at its 11 August assembly.
Lenacapavir is an HIV drug developed by US-based pharma firm, Gilead Sciences. It’s marketed as Sunlenca for treating folks with multidrug-resistant HIV and as Yeztugo for HIV prevention, or pre-exposure prophylaxis (PrEP), within the US. PrEP is medicine taken by individuals who wouldn’t have HIV to scale back their threat of being contaminated.
Gilead entered voluntary licensing agreements with six generic producers, together with India’s Dr Reddy’s Laboratories and Emcure Prescribed drugs, to provide and provide lenacapavir in 120 primarily low- and middle-income nations. Nevertheless, the generic variations nonetheless require regulatory approval in particular person nations.
The advice covers lenacapavir injection 463.5 mg/1.5 mL for PrEP to scale back the chance of sexually acquired HIV-1 in adults and adolescents weighing at the very least 35 kg who’re at elevated threat of buying HIV.
Nevertheless, the advice doesn’t quantity to remaining advertising approval. The SEC mentioned lenacapavir PrEP addresses an “unmet medical want” and beneficial waiving each the bioequivalence and native Section III trial necessities. Bioequivalence research examine whether or not a generic drug behaves within the physique in the identical manner as the unique drug, whereas Section III trials take a look at the drug’s security and effectiveness in a big group of individuals.
As soon as advertising authorisation is granted, each the businesses must submit their Section IV examine protocols to CDSCO inside three months for assessment by the committee.
Why the waiver issues
The advice might considerably shorten the time Indian producers would in any other case have wanted to deliver the drug to the home market. Chetali Rao, senior scientific and authorized researcher at Third World Community, mentioned that with out the waiver, Indian producers would doubtless have needed to conduct native Section III trials, which she estimated might have taken round “one-and-a-half, two years”.
“With the waiver coming, they may be capable of, as quickly because the product is there, they may instantly be capable of launch it,” Rao mentioned.
The event follows an earlier attraction by folks residing with HIV, weak communities, well being organisations and public-health consultants to Medicine Controller Common of India (DCGI) Rajeev Raghuvanshi, urging the regulator to expedite approval of generic lenacapavir and waive native Section III trial necessities.
Within the attraction, the group argued that lenacapavir had already proven sturdy leads to international Section III trials and had been accredited by main regulators. It known as for native Section III trials to be waived and for Section IV research to be performed as a substitute.
The group additionally highlighted the necessity for inexpensive generic variations, citing a goal value of $40 per individual per 12 months.
Rao mentioned the waiver was significantly important as a result of Indian producers have been capable of provide lenacapavir to different nations, whereas entry to the drug for HIV prevention has not but been out there in India.
Additionally Learn: HIV prevention jab in India soon at fraction of US cost? 2 drugmakers set to roll out generics
What occurs after approval
The SEC has made Section IV research a situation of the regulatory pathway. These research will generate post-marketing proof amongst individuals who want PrEP, relatively than requiring the businesses to repeat native Section III trials earlier than advertising authorisation.
The committee has additionally specified that people will need to have a destructive HIV-1 take a look at earlier than beginning lenacapavir.
Lenacapavir, developed by Gilead Sciences, is a long-acting HIV drug that targets the virus’s capsid, or outer shell. For HIV prevention, it’s given as an injection twice a 12 months after an preliminary oral dose.
The US Meals and Drug Administration accredited lenacapavir for PrEP in June 2025 below the model title Yeztugo, making it the primary twice-yearly injectable HIV prevention choice accredited within the US.
The drug’s effectiveness for prevention was demonstrated within the Section III PURPOSE trials. In PURPOSE 1, no HIV infections have been recorded amongst girls receiving twice-yearly lenacapavir. In PURPOSE 2, lenacapavir decreased HIV incidence by 96 p.c in contrast with estimated background incidence.
Present oral PrEP requires common dosing, which may make adherence troublesome for some folks due to stigma, privateness issues and difficulties accessing healthcare.
Waiver just for prevention, not therapy
The SEC’s suggestion applies solely to lenacapavir for HIV prevention and doesn’t cowl its use as a therapy. For Emcure’s utility to make use of lenacapavir in closely treatment-experienced folks with multidrug-resistant HIV-1, the committee mentioned there was not sufficient proof on how the drug behaves within the physique and whether or not its results might differ throughout ethnic teams.
It subsequently didn’t suggest waiving the native Section III trial requirement for the therapy indication.
Worth and entry
The transfer might additionally open the door to a considerably cheaper model of the drug in India. The sooner attraction by affected person teams to the DCGI had particularly known as for inexpensive generic lenacapavir. It additionally warned that delays in India’s approval might have an effect on entry in different low- and middle-income nations by pushing up costs and slowing scale-up.
The innovator model is presently priced at round $28,000 per 12 months, however below Gilead’s voluntary licensing association, generic producers can provide lenacapavir to 120 low- and middle-income nations at about $40 per 12 months.
The eventual value of generic lenacapavir in India shouldn’t be but clear and can depend upon the producers and their pricing selections.
Regulatory approval can be just one a part of making the drug accessible. In contrast to each day oral PrEP, lenacapavir is an injectable that needs to be administered twice a 12 months.
Rao mentioned that its inclusion in public HIV-prevention programmes, availability by means of healthcare services and the infrastructure required to manage an injectable drug will decide how broadly it reaches individuals who want it.
HIV testing may even stay necessary as a result of lenacapavir as PrEP is meant for individuals who wouldn’t have HIV.
(Edited by Nardeep Singh Dahiya)
Additionally Learn: UNAIDS 2025 report warns of funding gaps in fight against HIV as India battles stigma, discrimination
