FDA clears generic HIV shot, setting $40 annual cost target for 120 countries

The U.S. Food and Drug Administration has approved a generic version of lenacapavir, the only twice-a-year injection available for HIV prevention. This regulatory move is expected to accelerate the distribution of the medication in 120 low- and middle-income countries at a projected cost of $40 per person annually.

The announcement was made Monday by the drug’s manufacturer and partner organizations. This price point matches the current cost of daily preventive pills. However, the injection format requires dosing only twice a year. Clinical trials demonstrated that the shot nearly eliminated new infections among high-risk individuals, a performance that advocates argue surpasses the adherence challenges associated with daily oral medications.

Carmen Pérez Casas, the HIV lead for Unitaid, noted that daily pills require strict adherence to maintain protection. She stated that missing a dose leaves individuals vulnerable to the virus. The availability of the long-acting injection, she said, increases optimism for preventing new cases. The World Health Organization reported that 41 million people lived with HIV globally last year, while 570,000 died from related causes.

Carolyn Amole, who leads the HIV program at the Clinton Health Access Initiative, said the generic version could enable scaling to the 20 million people worldwide who need pre-exposure prophylaxis. She added that reaching this coverage level could help end the epidemic. The generic was developed by India-based Dr. Reddy’s Laboratories under an agreement brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI.

The FDA’s approval is designated as tentative. This status applies to generics while the originator product remains under patent. Gilead Sciences, which holds the patent for the brand-name version Yeztugo, has been the sole supplier until now. Demand in low- and middle-income countries has exceeded supply. Gilead established royalty-free licensing agreements with six generic manufacturers last year to address this shortfall.

The brand-name Yeztugo carries a U.S. list price of $28,218 per year before insurance. Gilead officials said this price is comparable to other types of pre-exposure prophylaxis. A Gilead spokesperson said in a statement that the company believes it enabled the fastest path to expanding access. The voluntary licenses cover specific regions in sub-Saharan Africa, Asia, and Latin America.

Generic lenacapavir cannot be sold in the United States until the patent on Yeztugo expires. Other generic versions produced by the remaining licensed manufacturers have not yet received FDA approval. The new drug from Dr. Reddy’s Laboratories is expected to reach some markets within weeks. However, countries that require their own regulatory approval processes may take longer to bring the medication to patients.

Saiqa Mullick, director of implementation science at Wits RHI, emphasized that patients must undergo HIV testing before starting the drug and with each injection. Drug-resistant HIV has been identified in cases where the medication was used by individuals with undiagnosed infections. Amole said the next steps require funding to purchase the drug and logistics to deliver it to those in need. She described the approval as a major milestone, though the work remains incomplete.