The U.S. Food and Drug Administration (FDA) announced on Wednesday a landmark approval for Gilead Sciences’ lenacapavir, a revolutionary twice-yearly injectable drug aimed at preventing HIV infection in adults and adolescents.
The drug will be marketed under the brand name Yeztugo.
This long-awaited decision has been met with immense anticipation from investors and AIDS activists alike, many of whom believe this drug could be a critical step towards ending the 44-year-old HIV epidemic.
Lenacapavir, belonging to a new class of medications called capsid inhibitors, demonstrated remarkable efficacy in large trials last year, proving nearly 100% effective in preventing HIV. This groundbreaking success has ignited fresh hope in disrupting the transmission of the virus, which currently infects 1.3 million people annually.
Its significance was further underscored when the academic journal Science named the experimental pre-exposure prophylaxis (PrEP) drug its 2024 Breakthrough of the Year.
“This is a milestone moment,” stated Gilead Chief Executive 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.”
Gilead is preparing for a swift launch of Yeztugo in the United States, with plans for a broader global rollout in collaboration with international partners.
