FDA Approves Generic Version of HIV Prevention Shot

Residents of 120 low- and middle-income countries may soon have access to a lower-cost version of the only twice-a-year injection available for HIV prevention. The U.S. Food and Drug Administration approved the generic version of lenacapavir on Monday, a regulatory step intended to make the drug more affordable and easier to distribute in regions with high infection rates.

The announcement was made by the drug’s manufacturer and the organizations that assisted in accelerating its development. Health officials stated that the new generic is expected to cost approximately $40 per person annually in the target countries. This price point matches the current cost of daily preventive pills, but the injection requires fewer doses and has shown high efficacy in reducing new infections among high-risk groups.

Carmen Pérez Casas, HIV lead for the grant-making organization Unitaid, noted that adherence to daily medication is a common barrier for patients. "People don't always take their daily dose of medication, and if you do not take it, you cannot get protected against HIV," Pérez Casas said. She added that the availability of lenacapavir offers greater hope for consistent protection.

Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, said the affordable generic could allow health systems to scale prevention efforts to the estimated 20 million people worldwide who need pre-exposure prophylaxis, or PrEP. "We can actually begin to bring an end to the HIV epidemic," Amole said. According to the World Health Organization, 41 million people were living with HIV globally last year, and 570,000 died from HIV-related causes.

Generic lenacapavir will not be sold in the United States because the brand-name version, Yeztugo, is protected by a patent held by Gilead Sciences. The U.S. list price for Yeztugo is $28,218 per year before insurance. Gilead officials stated that this price is comparable to other types of PrEP available in the market.

The FDA approved the generic under a practice designed to ensure the quality of HIV-related drugs provided by the U.S. government to other nations. This approval is designated as "tentative," a standard status for generics while the original drug remains under patent. The approval is expected to speed up regulatory processes in other countries that rely on FDA standards.

Until now, Gilead has been the sole supplier of lenacapavir. Demand in low- and middle-income countries has exceeded the available supply. Last year, Gilead established royalty-free licensing agreements with six generic manufacturers to increase production. These licenses cover specific regions in sub-Saharan Africa, Asia, and Latin America. A Gilead spokesperson said the company believes this approach provides the fastest and most sustainable path to expanding access.

The specific generic approved by the FDA was developed by India-based Dr. Reddy’s Laboratories. The agreement was brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI, a health research institute in Africa. The partners worked to accelerate the development timeline and reduce the final price for patients.

Common side effects of lenacapavir include injection site reactions, headache, and nausea. Patients must undergo HIV testing before starting the drug and with each subsequent injection. Saiqa Mullick, director of implementation science with Wits RHI, noted that rapid tests are typically used in low- and middle-income countries for this screening. Drug-resistant HIV has been identified in cases where the medication was used by people with undiagnosed infections.

Health officials said the generic should begin to reach some locations within weeks. However, the timeline may vary in countries that require their own domestic approval processes. Generic versions from other manufacturers have not yet received FDA approval. Amole said that while this is a major milestone, funding is still required to purchase the drug for all eligible patients and distribute it effectively.