US FDA approves Gilead’s twice-yearly injection for HIV prevention
The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences (GILD.O), opens new tab lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents.
Gilead said the drug will be sold under the brand name Yeztugo.
Investors and AIDS activists had been eagerly awaiting the regulatory decision for a drug some have said could help end the 44-year-old HIV epidemic.
Lenacapavir, part of a class of drugs known as capsid inhibitors, proved nearly 100% effective at preventing HIV in large trials last year, raising new hope of interrupting transmission of the virus that infects 1.3 million people a year.
The academic journal Science dubbed the experimental pre-exposure prophylaxis (PrEP) drug the 2024 Breakthrough of the Year.
“This is a milestone moment,” said Gilead Chief Executive Daniel O’Day of the approval.
“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 has plans for a rapid launch in the United States as well as a wider rollout of the drug in collaboration with global partners.
