FDA Approves Generic Lenacapavir for Global HIV Prevention

The U.S. Food and Drug Administration granted approval on Monday for a generic version of lenacapavir, the first medication designed to prevent HIV infection through two injections per year. The clearance allows the drug to be distributed at a reduced cost in 120 low- and middle-income countries. Manufacturers and health organizations involved in the development process announced the decision on Monday morning.

The approved generic is projected to cost $40 per person annually in the target markets. This price point matches the current annual cost of daily preventive pills. However, the injection regimen requires dosing far less frequently than oral medications. Clinical trials indicated the shot nearly eliminated new infections among high-risk individuals. Carmen Pérez Casas, the HIV lead for Unitaid, noted that daily pills require strict adherence for protection. She stated that the new injection offers a more reliable method for those who might miss daily doses.

Carolyn Amole, who directs the HIV program for the Clinton Health Access Initiative, said the affordable option could help provide pre-exposure prophylaxis to 20 million people worldwide. She added that scaling distribution to that level could begin to end the HIV epidemic. The World Health Organization reported that 41 million people lived with HIV globally last year, and 570,000 died from related causes.

Generic lenacapavir is not yet available in the United States because Gilead Sciences holds the patent for the brand-name version, Yeztugo. The U.S. list price for Yeztugo is $28,218 annually. Gilead officials said this price is comparable to other forms of pre-exposure prophylaxis. The FDA designated the generic approval as tentative, a standard status for generics while the original patent remains active. This approval can expedite regulatory processes in other nations.

Gilead previously held the sole supply rights for the drug, leading to shortages in developing regions. Last year, the company signed royalty-free licensing deals with six generic manufacturers. These agreements cover specific countries in sub-Saharan Africa, Asia, and Latin America. A Gilead spokesperson said the company believes it has created the fastest path to expanding access for affected communities. The initial generic was developed by Dr. Reddy’s Laboratories in India under an agreement brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI.

Health officials said the generic should reach some markets within weeks, though other countries may require additional local approvals. Common side effects of lenacapavir include injection site reactions, headaches, and nausea. Patients must test negative for HIV before starting treatment and receive testing at each injection. Saiqa Mullick, a director at Wits RHI, explained that rapid testing is common in many low- and middle-income countries. She emphasized that testing is a necessary step for any pre-exposure prophylaxis regimen.

Amole stated that funding is now required to purchase the drug for those in need. She described the next phase as the logistical work of distributing the medication to millions of patients. Pérez Casas expressed optimism that scientific tools, combined with political will and funding, will help curb the disease. She said the world now has the necessary tools to address the crisis.