Low-cost HIV prevention injection wins tentative FDA approval

Dr. Reddy’s Laboratories has secured tentative approval from the U.S. Food and Drug Administration for the first generic version of injectable lenacapavir, bringing a lower-cost HIV prevention option closer to people in 120 low- and middle-income countries.

The medicine is given twice a year and is expected to cost US$40 per person annually in those countries, about the same as daily prevention pills. In two major studies involving people at high risk of HIV, lenacapavir nearly eliminated new infections. Its long-lasting protection offers an alternative for people who find taking daily pills difficult.

The decision came just 16 months after approval of Gilead’s original product. Licensing agreements, together with financial, technical and regulatory support, helped accelerate the generic’s development. “Tentative” is the FDA designation for a generic while the original remains under patent; it does not permit sales in the United States.

Unitaid expects initial supplies to reach countries by the end of 2026. National approvals, funding and health services will still determine how quickly people can benefit. HIV testing is required before starting lenacapavir and at every injection, because using it with an undiagnosed infection can lead to drug resistance. Approval is an important step, but delivering the medicine to those who need it remains the next task.