Washington (US), Nov 3 : The US Food and Drug Administration (FDA) has granted approval to an India-made generic version of lenacapavir, the world’s only twice-yearly injection for HIV prevention, in a major step towards expanding affordable access to the drug across 120 low- and middle-income countries.
The announcement was made on Monday by the manufacturer and organisations involved in accelerating the development of the medication.
The generic version was developed by India-based Dr. Reddy’s Laboratories under an agreement facilitated by Unitaid, the Clinton Health Access Initiative and Wits RHI, an African health research institute. The partnership aimed to speed up production and ensure the drug reaches people at an affordable price.
The injection is expected to cost around USD 40 per person annually in the countries where it will be available, matching the current cost of daily HIV-prevention pills. However, lenacapavir offers greater convenience as it requires administration only twice a year.
Two major clinical studies involving people at high risk of HIV showed that the injection nearly eliminated new infections.
Health experts believe the long-acting medication could address a major challenge associated with daily preventive pills, which people may find difficult to take consistently.
“With lenacapavir, we are much more hopeful,” said Carmen Perez Casas, HIV lead at Unitaid, highlighting the benefits of a preventive option that does not require daily medication.
According to the World Health Organization (WHO), around 41 million people worldwide were living with HIV last year, while approximately 570,000 died from HIV-related causes.
Carolyn Amole, who heads the HIV programme at the Clinton Health Access Initiative, said affordable generic availability could help expand access to pre-exposure prophylaxis (PrEP), preventive medication taken by people at risk of HIV before exposure to the virus.
She said the aim would be to reach around 20 million people globally who need PrEP, adding that wider access could help bring the HIV epidemic under control.
Major Price Difference Between Generic And Branded Versions
The generic version cannot be sold in the United States while the branded drug, Yeztugo, manufactured by Gilead Sciences, remains protected by a patent. The branded version was approved last year and carries a US list price of USD 28,218 annually, before insurance.
Gilead has so far been the sole supplier of lenacapavir. However, demand in low- and middle-income countries has exceeded available supplies.
Last year, the company entered into royalty-free licensing agreements with six generic manufacturers to expand production. These agreements cover specified countries across sub-Saharan Africa, Asia and Latin America.
The FDA granted tentative approval to the Indian generic under a longstanding mechanism designed to ensure the quality of HIV-related medicines supplied to other countries through US government programmes.
Such approval can also help accelerate regulatory clearances in other countries. The tentative designation is used for generic medicines when the original branded product remains under patent protection.
A Gilead spokesperson said the company shared the urgency of expanding access to lenacapavir and believed its licensing arrangements offered a sustainable route to reaching communities most affected by HIV.
Testing Essential Before Every Injection
Common side effects of lenacapavir include reactions at the injection site, headaches and nausea.
Health experts have also stressed that people must undergo HIV testing before starting the medication and before receiving each subsequent injection. Drug-resistant HIV has been identified in cases where the injection was administered to people with an undiagnosed infection.
Saiqa Mullick, director of implementation science at Wits RHI, said HIV testing was essential before starting any form of PrEP, adding that rapid tests were commonly used in many low- and middle-income countries.
The generic version is expected to become available in some countries within weeks, although access may take longer in places where separate regulatory approvals are required.
Other generic manufacturers are yet to receive FDA approval for their versions.
Health advocates have described the development as a major milestone but cautioned that sustained funding and distribution efforts will be necessary to ensure the medicine reaches millions of people who need it.
“This is a great milestone,” Amole said, while emphasising that the next challenge would be securing funds and ensuring widespread availability.
Unitaid’s Carmen Perez Casas expressed optimism that scientific progress, political commitment and adequate funding could help the world make significant advances in tackling HIV.
