The US Food and Drug Administration (FDA) has granted tentative approval to an India-developed generic version of lenacapavir, a long-acting injectable drug for HIV prevention, paving the way for its wider availability across 120 low- and middle-income countries.
Developed by Dr Reddy’s Laboratories in collaboration with global health organisations, the generic formulation is expected to significantly reduce the cost of HIV prevention. The initiative was facilitated through an agreement involving Unitaid, the Clinton Health Access Initiative and South Africa-based Wits RHI.
The twice-yearly injection is expected to be available at approximately USD 40 per person annually in eligible countries, bringing it in line with the cost of existing daily oral pre-exposure prophylaxis (PrEP) medication. Its extended dosing schedule could improve treatment adherence among people at risk of HIV infection.
Lenacapavir has demonstrated substantial effectiveness in preventing new HIV infections in clinical studies, offering an alternative to daily preventive medication. PrEP is prescribed to individuals at risk of contracting HIV and is taken before potential exposure to the virus.
The FDA’s tentative approval was granted under its established review pathway for HIV-related medicines intended for use in other countries. While the approval confirms that the generic meets the required quality standards, commercial distribution in the US remains restricted due to patent protection on Gilead Sciences’ branded formulation, Yeztugo.
Gilead’s branded version carries a US list price of approximately USD 28,218 annually. The company has previously entered into royalty-free licensing agreements with six generic manufacturers to expand access in selected countries across Africa, Asia and Latin America.
The generic formulation is expected to begin reaching some countries within weeks, although availability will depend on individual national regulatory approvals and procurement arrangements.
Health experts have also highlighted the importance of HIV testing before initiating treatment and before subsequent injections, as undiagnosed HIV infection during lenacapavir use may contribute to drug resistance.
The approval represents a significant development in expanding access to long-acting HIV prevention, although sustained funding, healthcare delivery infrastructure and wider national regulatory clearances will be essential to reach the millions of people who could benefit from the medication.