FDA approves generic HIV shot for low-income nations

The U.S. Food and Drug Administration approved a generic version of lenacapavir on Monday morning.

The medication is the only available twice-yearly injection for HIV prevention. The approval is expected to lower costs and increase access in 120 low- and middle-income countries.

Gilead Sciences has been the sole supplier of lenacapavir since the brand-name version, Yeztugo, received approval last year. Demand in lower-income regions has exceeded the available supply. Gilead established royalty-free licensing agreements with six generic manufacturers to increase production. These voluntary licenses cover specific countries in sub-Saharan Africa, Asia, and Latin America.

India-based Dr. Reddy’s Laboratories developed the new generic version. The project was brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI, a health research institute in Africa. The partners aimed to accelerate development and set an affordable price point.

The FDA granted the approval under a longstanding practice designed to ensure the quality of HIV drugs provided to other countries by the U.S. government. The designation is considered tentative while the originator remains under patent. Approval by the FDA often speeds regulatory review in other nations.

The generic drug is expected to cost $40 per person per year in the countries where it will be available. That price matches the cost of current daily preventive pills. The injections require less frequent administration than the pills. Two studies showed the shots nearly eliminated new infections in people at high risk.

Carmen Pérez Casas, HIV lead for Unitaid, noted that patients do not always take daily doses. She stated that protection fails if the daily medication is missed. Casas said the team is much more hopeful with the injection option.

Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, said the affordable generic could help scale treatment to 20 million people worldwide who need pre-exposure prophylaxis. She added that reaching those levels could help bring an end to the HIV epidemic.

The World Health Organization reported that 41 million people were living with HIV last year. The organization also reported that 570,000 people died from HIV-related causes in the same period.

Gilead officials said the U.S. list price for Yeztugo is $28,218 per year before insurance. They noted the price is similar to other types of pre-exposure prophylaxis. A Gilead spokesperson said the company shares the sense of urgency around expanding access. The spokesperson added that the company believes it enabled the fastest path to expanding access for affected communities.

Common side effects for lenacapavir include injection site reactions, headache, and nausea. Patients must undergo HIV testing before starting the drug and with each injection. Drug-resistant HIV has been identified when the medication is used by people with an undiagnosed infection.

Saiqa Mullick, director of implementation science with Wits RHI, said HIV testing in advance is required for any pre-exposure prophylaxis. She noted that rapid tests are commonly used in low- and middle-income countries for this purpose. Generic lenacapavir should become available in some places within weeks. It may take longer in countries that require their own approval processes. Generic versions from other manufacturers have not yet received FDA approval. Amole said funding is now needed to buy the drug for everyone who needs it. Casas said the world now has the tools to curb HIV.