FDA approves generic version of twice-yearly HIV prevention shot

The U.S. Food and Drug Administration has approved a generic version of lenacapavir, the only medication available as a twice-yearly injection to prevent HIV. This regulatory move is expected to lower costs and expand access in 120 low- and middle-income countries. The announcement was made on Monday morning by the manufacturer and partner organizations.

The generic drug is projected to cost $40 per year for each patient in the target markets. This price point matches the current cost of daily preventive pills, known as pre-exposure prophylaxis or PrEP. However, the injection offers a distinct advantage in convenience because patients need it far less frequently.

Clinical trials demonstrated that the shots nearly eliminated new infections among people at high risk. Carmen Pérez Casas, the HIV lead for Unitaid, noted that daily pills require strict adherence to maintain protection. She stated, “and if you do not take it, you cannot get protected against HIV.” Pérez Casas added that the availability of the injectable version offers greater hope for preventing transmission.

Global health advocates argue that an affordable and high-quality generic option could help reduce the global burden of HIV. The World Health Organization reported that 41 million people were living with HIV last year. During that same period, 570,000 people died from HIV-related causes. Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, said the new option allows for scaling up to the 20 million people worldwide who need PrEP.

Amole suggested that reaching this scale could help bring an end to the HIV epidemic. She added, “And if we scale to those levels, we can actually begin to bring an end to the HIV epidemic.” The organization aims to distribute the medication to populations most affected by the virus.

The generic version will not be sold in the United States immediately. A brand-name version called Yeztugo, manufactured by Gilead Sciences, remains under patent protection. Gilead received FDA approval for Yeztugo last year. The U.S. list price for the brand-name drug is $28,218 per year before insurance. Gilead officials said this price is comparable to other forms of PrEP.

The FDA approved the generic under a specific practice designed to ensure the quality of HIV drugs supplied by the U.S. government to other nations. This approval is designated as tentative, a standard status for generics while the original drug remains patented. Approval by the FDA often accelerates regulatory decisions in other countries.

Dr. Reddy’s Laboratories, based in India, developed the generic version. The project was brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI, a health research institute in Africa. These partners worked to speed up development and secure an affordable price. Last year, Gilead established royalty-free licensing agreements with six generic manufacturers to enable production in sub-Saharan Africa, Asia, and Latin America.

A Gilead spokesperson said in a statement, “We share the sense of urgency around expanding access to lenacapavir for HIV prevention.” The company believes it has enabled the fastest path to expanding access for affected communities. Common side effects of the medication include injection site reactions, headache, and nausea.

Patients must be tested for HIV before starting the drug and with each injection. Drug-resistant HIV has been identified in cases where the medication was used by individuals with an undiagnosed infection. Saiqa Mullick, director of implementation science with Wits RHI, noted that testing in low- and middle-income countries often relies on rapid tests. Generic lenacapavir is expected to become available in some regions within weeks, though countries with their own approval processes may face delays. Other generic versions have not yet received FDA approval. Amole said, “The work is not done. Now, we need the funding to actually buy it for everyone who needs it.”