FDA approves Gilead’s groundbreaking twice-yearly HIV prevention injection

The United States Food and Drug Administration (FDA) has approved a new HIV prevention drug by Gilead Sciences, marking a significant step forward in the fight against the global HIV epidemic.

The injection, known as lenacapavir, will be marketed under the brand name Yeztugo and is designed to be administered just twice a year.

The approval, announced on Wednesday, comes after lenacapavir showed near-perfect efficacy in large clinical trials last year.

The drug belongs to a new class of antiretrovirals known as capsid inhibitors, which work by targeting the protective shell of the virus. Studies found it to be nearly 100% effective at preventing HIV infection, offering new hope to millions at risk.

“This is a milestone moment,” said Gilead CEO Daniel O’Day. “We believe that lenacapavir is the most important tool we have yet to bend the arc of the epidemic and move this epidemic into the history books.”

The breakthrough has been widely welcomed by public health experts, researchers, and HIV/AIDS advocacy groups. In 2024, the respected journal Science named lenacapavir the Breakthrough of the Year, underscoring its potential to transform HIV prevention strategies worldwide.

Lenacapavir’s approval is especially significant in light of ongoing efforts to end the HIV epidemic, which still sees approximately 1.3 million new infections annually. Unlike daily pills or more frequent injections, Yeztugo offers a low-maintenance option for individuals seeking pre-exposure prophylaxis (PrEP), especially in high-risk populations.

Gilead has announced plans for a rapid rollout in the U.S. and is partnering with global health agencies to expand access worldwide, particularly in regions with high infection rates and limited medical infrastructure.

As excitement builds around Yeztugo’s global launch, the drug is being hailed as a game-changing advancement that could push the world closer to an HIV-free future.

Source: Reuters

The post FDA approves Gilead’s groundbreaking twice-yearly HIV prevention injection first appeared on 3News.