A generic version of the world’s only twice-yearly injectable drug for preventing HIV has been approved by the U.S.

Food and Drug Administration, marking a significant step toward delivering affordable, rapid access to the medication across 120 low- and middle-income countries.

The pharmaceutical manufacturer released the announcement on Monday morning alongside global organizations that worked to accelerate development of the preventative treatment, lenacapavir.

The medication is projected to cost $40 per person annually in the designated recipient nations—matching the current price of daily preventative oral pills.

However, the injections provide a far more convenient alternative to daily tablets due to their reduced administration frequency, and they virtually eliminated new HIV cases during two groundbreaking clinical trials involving individuals at high risk.

Maintaining a daily medication regimen poses ongoing challenges, "and if you do not take it, you cannot get protected against HIV," said Carmen Pérez Casas, HIV lead for the grant-making organization Unitaid, a global health agency.

"With lenacapavir, we are much more hopeful." Health advocates emphasize that widespread access to the drug could significantly decrease overall HIV and AIDS diagnoses as well as related fatalities.

Data from the World Health Organization shows that 41 million people globally were living with HIV last year, with 570,000 deaths recorded from HIV-related conditions.

With an affordable, high-quality generic medication now available, "we could help to scale this to the 20 million people around the world who need PrEP," prescription medicine taken by people at risk of HIV before being exposed to the virus, said Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, a global health organization.

"And if we scale to those levels," she added, "we can actually begin to bring an end to the HIV epidemic." The generic form of lenacapavir cannot be marketed within the U.S.

because the brand-name version, Yeztugo, manufactured by Gilead Sciences and cleared by regulators last year, remains protected under active patent laws.

In the U.S., Yeztugo's list price, before insurance adjustments, stands at $28,218 per year.

Gilead representatives state that this cost is comparable to other available forms of PrEP, an acronym for pre-exposure prophylaxis.....