FDA clears $40 HIV shot for global rollout

A new medical option for preventing HIV has cleared a major regulatory hurdle in the United States. The U.S. Food and Drug Administration approved a generic version of lenacapavir on Monday. This drug is the only available option that requires injection only twice a year.

The approval is expected to allow the medication to be sold for $40 per person annually in 120 low and middle income countries. That price matches the current cost of daily preventive pills. The generic version was developed by India-based Dr. Reddy’s Laboratories. It was created under agreements brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI.

Carmen Pérez Casas, the HIV lead at Unitaid, noted that daily pills often go unmissed, leaving people vulnerable. She stated that with lenacapavir, the organization is much more hopeful. Carolyn Amole, who leads the HIV program at the Clinton Health Access Initiative, said the affordable generic could help scale treatment to the 20 million people worldwide who need pre-exposure prophylaxis.

Gilead Sciences, the maker of the brand-name version Yeztugo, holds a patent that prevents the generic from being sold in the U.S. market. The U.S. list price for the brand-name shot is $28,218 a year. Gilead officials say this price is similar to other types of pre-exposure prophylaxis. Last year, Gilead established royalty-free licensing agreements with six generic manufacturers to help meet demand in regions where supply had fallen short.

The FDA’s approval is designated as tentative, a standard practice for generics while the originator remains under patent. This status is intended to ensure quality and speed regulatory approval in other nations. Generic lenacapavir should start arriving in some locations within weeks, though countries with their own approval processes may take longer.

Users must be tested for HIV before starting the drug and with each injection. Drug-resistant HIV has been found in people who had an undiagnosed infection while using the medication. Common side effects include injection site reactions, headache, and nausea. Saiqa Mullick, director of implementation science with Wits RHI, noted that for many low and middle income countries, the required advance testing is a rapid test.

The World Health Organization reported that 41 million people were living with HIV last year. An additional 570,000 died from HIV related causes. Gilead spokespersons said in a statement that they believe they have enabled the fastest path to expanding access for communities most affected by the virus. Amole added that the work is not done and that funding is now needed to buy the drug for everyone who needs it.