FDA approves first generic of twice-yearly HIV injection: US$40 a year in 120 countries

Washington.— The United States Food and Drug Administration (FDA) on Monday granted tentative approval to the first generic version of lenacapavir, the twice-yearly injection that prevents HIV infection, a step that will bring the treatment to 120 low- and middle-income countries at an estimated cost of $40 per person per year.

The drug, developed by Indian pharmaceutical company Dr. Reddy's Laboratories in partnership with Unitaid, the Clinton Health Access Initiative (CHAI) and the Wits RHI institute, replaces a daily pill with two injections a year. In earlier clinical trials in high-risk populations, the medicine showed efficacy close to 100% in eliminating new infections.

Lenacapavir is part of pre-exposure prophylaxis (PrEP), a strategy for people without HIV who face situations of risk. It acts on the virus's capsid and intervenes at different stages of its life cycle. It requires an HIV test before starting the regimen and before each dose, and it does not protect against other sexually transmitted infections.

The generic version cannot be sold in the United States, where the brand-name version, registered as Yeztugo by Gilead Sciences, remains under patent protection with a list price of $28,218 per year. For lower-income countries, Gilead granted royalty-free licenses to six generic manufacturers in late 2024, including Dr. Reddy's.

The approval is tentative because the patent is still in force, but the FDA protocol for HIV medicines funded by the U.S. government abroad will speed up approvals in recipient countries. The first deliveries are expected before the end of 2026, with broader distribution planned for 2027.

"This is a moment of immense pride for all of us at Dr. Reddy's," said Deepak Sapra, the company's director of pharmaceutical services, about a long-acting injectable that "required strong scientific capabilities." Unitaid director Philippe Duneton said that "taking risks early on" is shortening the time between scientific breakthroughs and real access.

More than 125,000 people in ten African countries have already begun receiving lenacapavir, and the generic aims to expand that reach against a disease that has killed more than 40 million people in four decades.

Photo: Archivo A Lo Claro

Source: NX Noticias