FDA Approves Generic HIV Shot Priced at $40 Per Year
The new lenacapavir generic targets 120 low- and middle-income countries, matching the cost of current daily pills while requiring injections only twice a year.
By Rafael Collins ·
The U.S. Food and Drug Administration has cleared a generic version of lenacapavir, the only twice-yearly injection available for HIV prevention. The approval, announced Monday morning by the manufacturer and partner organizations, aims to lower costs and accelerate distribution in 120 low- and middle-income nations.
The new medication is projected to cost $40 per person annually in the target markets. This price matches the current cost of daily preventive pills. Lenacapavir requires administration only twice a year, a schedule that reduces the burden on patients who may miss daily doses. In two major studies involving high-risk individuals, the shots nearly eliminated new infections.
Carmen Pérez Casas, HIV lead for Unitaid, noted that protection fails if daily pills are not taken. "With lenacapavir, we are much more hopeful," she said. Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, stated that the affordable generic could help expand pre-exposure prophylaxis to the 20 million people worldwide who need it.
Global health agencies emphasize the potential to reduce the 41 million people currently living with HIV and the 570,000 deaths from HIV-related causes recorded last year. Amole added that scaling distribution to those levels could help bring an end to the epidemic.
The brand-name version, Yeztugo, is manufactured by Gilead Sciences and was approved last year. It remains protected by a patent in the United States, where the list price is $28,218 per year. Gilead officials described this price as comparable to other types of pre-exposure prophylaxis. In international markets, Gilead previously held the sole supply, leading to demand that exceeded availability in many regions.
Last year, Gilead established royalty-free licensing agreements with six generic manufacturers. These licenses cover specific countries in sub-Saharan Africa, Asia, and Latin America. The current FDA clearance applies to the generic developed by India-based Dr. Reddy’s Laboratories, a project brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI. The FDA designated the approval as tentative, a standard status for generics while the originator patent remains active.
Users of lenacapavir must undergo HIV testing before starting the drug and with each injection. Common side effects include injection site reactions, headache, and nausea. Saiqa Mullick, director of implementation science with Wits RHI, said rapid testing is the standard for many low- and middle-income countries. Generic lenacapavir may become available in some locations within weeks, though other nations may require their own regulatory reviews.
