FDA clears generic HIV shot set to cost $40 per year

The U.S. Food and Drug Administration approved a generic version of lenacapavir on Monday. The drug is the only available injection for HIV prevention that requires dosing only twice a year. This approval moves the medication closer to widespread, low-cost availability in 120 low- and middle-income countries.

The generic formulation is projected to cost $40 per person annually in target markets. That price matches the current cost of daily oral prevention pills. The injection format offers a distinct advantage in patient compliance. In two studies involving people at high risk, the shot nearly eliminated new infections. Carmen Pérez Casas, HIV lead for the grant-making organization Unitaid, noted that daily pills fail to protect users if they miss a dose. She stated that the new shot offers much greater hope for protection.

Global health advocates believe the affordable generic will help reduce the number of people living with HIV. The World Health Organization reported that 41 million people worldwide lived with the virus in the previous year. HIV-related causes accounted for 570,000 deaths in that same period. Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, said the medication should help scale prevention efforts to the 20 million people globally who need it. She added that reaching those levels could help end the epidemic.

The generic is not yet available for sale in the United States. Gilead Sciences holds a patent on its brand-name version, Yeztugo, which was approved last year. The list price for the brand-name drug in the U.S. is $28,218 per year before insurance. Gilead officials say this cost is similar to other types of pre-exposure prophylaxis. The FDA designated the new generic as tentative, a standard classification used while the originator drug remains under patent.

Until now, Gilead was the sole supplier of lenacapavir. Demand in low- and middle-income countries has exceeded supply. Last year, Gilead signed royalty-free licensing agreements with six generic manufacturers. These voluntary licenses cover specific countries in sub-Saharan Africa, Asia, and Latin America. A Gilead spokesperson said in a statement that the company believes it enabled the fastest path to expanding access for affected communities.

Dr. Reddy’s Laboratories, based in India, developed the first approved generic. The project was brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI. Common side effects include injection site reactions, headache, and nausea. Patients must undergo HIV testing before starting the drug and with each injection to prevent drug-resistant strains. Saiqa Mullick, director of implementation science with Wits RHI, explained that rapid testing is the standard method in many target countries.

Officials expect the generic to become available in some regions within weeks. It may take longer in countries that require their own regulatory approval processes. Other generic versions are currently awaiting FDA approval. Amole said the next steps involve securing funding to purchase the drug and distributing it to those who need it.

Pérez Casas expressed optimism that scientific advances and political will can curb HIV. She said the world now has the necessary tools.