FDA approves generic HIV shot for 120 low-income countries at $40 per year

The U.S. Food and Drug Administration has approved a generic version of lenacapavir, the world’s only twice-a-year injection to prevent HIV. The approval is intended to make the drug available more quickly and at a lower cost in 120 low- and middle-income countries.

The generic version is expected to cost about $40 per person per year in eligible countries, matching the price of currently available daily preventive pills. Because the injection is needed only twice a year, it is far more convenient than a daily pill regimen.

“With lenacapavir, we are much more hopeful.”

In two major clinical studies involving people at high risk of HIV, the drug nearly eliminated new infections. Health experts note that many people do not take daily medication consistently, and missing doses means they cannot be protected against HIV.

According to the World Health Organization, 41 million people worldwide were living with HIV, and 570,000 people died from HIV-related causes last year. Advocates estimate that 20 million people around the world need PrEP, the pre-exposure prophylaxis taken before potential exposure to the virus.

The brand-name version, Yeztugo, is made by Gilead Sciences and remains under patent protection in the United States. Its U.S. list price before insurance is $28,218 per year, and generic lenacapavir cannot be sold in the U.S. while that patent stands.

The generic was developed by India’s Dr. Reddy’s Laboratories under an agreement coordinated by Unitaid, the Clinton Health Access Initiative, and the Wits RHI medical research institute. The FDA approved it under a longstanding practice designed to ensure the quality of HIV medications.

Carmen Pérez Casas, HIV lead for Unitaid, said people do not always take their daily dose, and without it they cannot be protected. Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, said scaling access to 20 million people could actually help bring an end to the HIV epidemic.