WASHINGTON, Nov 2: An India developed generic version of lenacapavir, a long-acting injection that offers protection against HIV with just two doses a year, has received approval from the US Food and Drug Administration (FDA), paving the way for wider and more affordable access in 120 low and middle income countries.
The announcement was made on Monday by Dr. Reddy’s Laboratories and international organisations involved in accelerating the development of the generic medication. The initiative was coordinated through an agreement facilitated by Unitaid, the Clinton Health Access Initiative and South Africa based Wits RHI.
The injection is expected to be priced at around USD 40 per person annually in eligible countries, bringing it in line with the cost of existing daily preventive medication. However, its twice-yearly administration offers a significant advantage for individuals who find it difficult to maintain a regular pill-taking schedule.
Clinical trials have demonstrated remarkable results, with lenacapavir almost completely preventing new HIV infections among participants at high risk. Health experts believe its extended protection could improve adherence to preventive treatment and strengthen efforts to control the spread of the virus.
Carmen Perez Casas, HIV lead at Unitaid, said the injection offered renewed hope because individuals would no longer need to remember to take medication every day to remain protected.
According to the World Health Organization, approximately 41 million people were living with HIV worldwide last year, while around 570,000 deaths were attributed to HIV related causes.
Carolyn Amole, who heads the HIV programme at the Clinton Health Access Initiative, said affordable generic production could help extend pre-exposure prophylaxis (PrEP) to nearly 20 million people globally who require protection against the virus.
She expressed confidence that expanding access to the medication could contribute significantly to ending the HIV epidemic.
The generic formulation, however, will not be available for sale in the United States, where Gilead Sciences holds patent protection for its branded version, Yeztugo, which received approval last year. The branded injection carries a list price of USD 28,218 annually before insurance coverage.
Gilead has so far been the sole supplier of lenacapavir. However, growing demand in developing countries has exceeded available supplies, prompting the company to enter into royalty free licensing agreements with six generic drug manufacturers last year.
These agreements allow production for designated countries across sub-Saharan Africa, Asia and Latin America. A company spokesperson said Gilead remained committed to expanding access to the medication through a sustainable supply strategy.
The FDA granted tentative approval to the Indian generic under a regulatory mechanism intended to ensure the quality and safety of HIV-related medicines supplied to developing countries through US supported programmes.
Although the designation does not permit commercial marketing in the US while the original product remains under patent, it can help accelerate regulatory clearances in other countries.
The injection may cause side effects such as pain or reactions at the injection site, headaches and nausea. Medical professionals have also emphasised the importance of HIV testing before treatment begins and before subsequent injections, as administering the drug to someone with an undiagnosed infection could contribute to drug resistance.
Saiqa Mullick, director of implementation science at Wits RHI, said rapid HIV testing could help address this requirement in many low- and middle-income countries.
The first supplies of the generic medication could reach some countries within weeks, although distribution timelines will depend on individual national regulatory procedures. Other generic manufacturers are still awaiting FDA approval for their versions.
Health advocates have described the development as a major breakthrough but stressed that financial support, procurement and distribution networks will be essential to ensure that the medication reaches those who need it.
Amole said securing funding and delivering the injection to millions of potential beneficiaries would be the next major challenge, despite the significant progress achieved through the approval.
Experts believe the availability of an affordable, long acting preventive treatment could transform HIV prevention, particularly in communities where access to regular healthcare and daily medication remains limited.