FDA Clears Generic HIV Shot for Global Distribution

The U.S. Food and Drug Administration has approved a generic version of lenacapavir, the only medication available as a twice-yearly injection for HIV prevention. The move opens the door to supplying the drug in 120 low- and middle-income countries at a price point comparable to daily oral pills.

The approval was announced on Monday by the manufacturer and partners who facilitated the drug's development. The new generic is expected to cost $40 per person per year in eligible nations. This matches the current cost of daily preventive pills but offers a more convenient dosing schedule that requires fewer visits to healthcare providers.

Two studies involving people at high risk of infection found that the shots nearly eliminated new HIV cases. Carmen Pérez Casas, the HIV lead for the grant-making organization Unitaid, noted that daily pills fail to protect patients who miss doses. She stated that the injection format offers a higher likelihood of consistent protection for those at risk.

Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, said the affordable generic could allow for scaling distribution to 20 million people worldwide who require pre-exposure prophylaxis. She added that reaching that volume could help bring an end to the HIV epidemic. The World Health Organization reported that 41 million people were living with HIV globally last year, with 570,000 deaths attributed to the virus.

The generic cannot be sold in the United States because the brand-name version, Yeztugo, is still protected by patent. Gilead Sciences, which manufactures Yeztugo, lists the U.S. price at $28,218 per year before insurance. Gilead officials described this cost as similar to other types of pre-exposure prophylaxis available in the market.

The FDA approved the generic under a specific practice designed to ensure quality for HIV drugs provided to other countries by the U.S. government. This approval is designated as tentative while the originator remains under patent. Gilead had previously been the sole supplier of lenacapavir, leading to supply shortages in low- and middle-income countries. The company established royalty-free licensing agreements with six generic manufacturers last year to address this gap.

A Gilead spokesperson said in a statement that the company believes it has enabled the fastest path to expanding access for communities most affected by HIV. The specific generic approved this week was developed by India-based Dr. Reddy’s Laboratories. The development was brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI, a health research institute in Africa.

Common side effects for 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 for many low- and middle-income countries, this testing will rely on rapid tests. Drug-resistant HIV has been identified when the medication was used by people with undiagnosed infections.

Partners in the effort said the generic should become available in some locations within weeks. However, countries that require their own regulatory approval processes may experience longer wait times. Generic versions produced by other manufacturers have not yet received FDA approval. Carolyn Amole stated that funding is now needed to purchase the drug for all eligible patients and to distribute it effectively.

Carmen Pérez Casas expressed optimism that scientific advances, political will, and funding can help curb HIV globally. She concluded that the world now has the necessary tools to address the crisis. Gerald Imray in Cape Town, South Africa, contributed to the reporting.