Dr Reddy’s Laboratories has received tentative approval from the United States Food and Drug Administration (USFDA) for its generic version of lenacapavir, a long-acting injectable medicine used for HIV prevention.
The approval marks a significant development in efforts to improve access to HIV prevention medicines, particularly in low- and middle-income countries.
Lenacapavir is administered twice a year for pre-exposure prophylaxis (PrEP), a preventive treatment designed to reduce the risk of acquiring HIV-1 through sexual exposure. The medicine is intended for adults and adolescents weighing at least 35 kilograms who are eligible for the treatment.
Dr Reddy’s said it is the first among six licensed generic manufacturers to receive tentative USFDA approval for the medicine.
The drug, originally developed by Gilead Sciences and marketed in the United States under the brand name Yeztugo, has attracted attention because of its long-acting formulation. Its twice-yearly dosing schedule could offer an alternative to daily preventive medicines.
The tentative approval does not immediately permit commercial sales in the United States. Patent and exclusivity restrictions remain applicable. However, the regulatory assessment could support approvals and procurement through licensing arrangements in approximately 120 low- and middle-income countries.
Global health organisations are working to make generic versions available at substantially lower prices. Estimates indicate that the generic medicine could eventually cost around $40 per person annually, compared with the much higher price of the branded treatment in the US market.
Initial supplies may reach selected lower-income countries by the end of 2026, with wider distribution expected during 2027.
The development is being viewed as an important step towards expanding access to long-acting HIV prevention options.
Health experts and global organisations continue to emphasise that affordable preventive medicines, testing services, awareness programmes and sustained public health efforts are essential to reducing new HIV infections.
The approval could strengthen the availability of additional prevention choices for people at risk of HIV infection.
Source: Regulatory announcement and company information.
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