Game-Changer in HIV Prevention: Lenacapavir's Historic Approval

The FDA has approved Gilead Sciences' lenacapavir, sold as Yeztugo, as a biannual injection to prevent HIV, signaling a pivotal step towards ending the epidemic. Priced at $28,218 annually, it offers hope for better adherence compared to daily PrEP pills. Gilead plans a swift U.S. launch and broader distribution globally.

The U.S. Food and Drug Administration (FDA) granted approval for Gilead Sciences' lenacapavir, marketed as Yeztugo, marking a significant milestone in HIV prevention. The drug, designed for twice-yearly injection, emerges as a powerful tool with the potential to fundamentally change the trajectory of the epidemic.

Lenacapavir, a capsid inhibitor, was proven to be nearly 100% effective in clinical trials, making it a promising successor to daily PrEP pills. With a list price of $28,218 per year, the drug's approval has sparked optimism for its potential to reduce the annual infection rate of 1.3 million globally.

Gilead Chief Executive Daniel O'Day expressed determination to implement a rapid U.S. launch while expanding access in collaboration with global partners. Although challenges such as funding cuts have emerged, there remains hope that organizations like PEPFAR and the Global Fund will support this preventive strategy.

(With inputs from agencies.)