The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences lenacapavir, a twice-yearly injection, for preventing HIV infection in adults and adolescents.
Investors and AIDS activists had been eagerly awaiting the regulatory decision for the drug with the potential to help end the 44-year-old HIV epidemic.
The drug will be sold under the brand name Yeztugo in the U.S. at a list price of $28,218 a year.
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.
Drugs to prevent HIV, known as pre-exposure prophylaxis or PrEP, are widely available, but most are daily pills that require strict adherence to be effective.
"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," O'Day said.
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.
Gilead Chief Commercial Officer Johanna Mercier said the company's "end game" is to normalize PrEP usage, both in the United States and other countries, including low-income African nations where the virus is most prevalent.
Mercier said she expects around 75% of U.S. insurers, including government health plans, will cover lenacapavir for PrEP within about six months, with the number rising to 90% within 12 months of launch.
The drug is currently sold as a treatment in the U.S. under the brand name Sunlenca for patients with advanced disease that has become resistant to other drugs.
In December, the President's Emergency Plan for AIDS Relief (PEPFAR) under then-President Joe Biden signed an agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria to provide the treatment to as many as 2 million people for three years if it won U.S. regulatory approval for prevention.
That would allow for unprecedented early access to a state-of-the-art treatment, as six generic drugmakers who have licensed the product from Gilead gear up for production of low-cost versions in 120 resource-limited countries.
AIDS activists have viewed the drug as a way to significantly slow the epidemic, but cuts to PEPFAR by the Trump administration have raised concerns about the U.S. government's commitment to the rollout.
O'Day acknowledged that the changes have been "challenging," but said the company has continued to have discussions with both the Global Fund and PEPFAR.
"I believe that there will be sources of funding for this, and that these organizations will prioritize this type of prevention," he said.