The United States Food and Drug Administration (FDA) has approved a twice-a-year injectable drug to be used for HIV prevention.
A statement issued by Gilead Sciences, maker of the drug, said the injection of Lenacapavir has been approved in the United States for HIV prevention under the brand name Yeztugo.
In clinical trials, the drug was found to greatly reduce the risk of infection and provide almost total protection against HIV.
The efficacy was found to be significantly higher than that of the primary options available for pre-exposure prophylaxis (PrEP). Therapies called PrEP have been used to prevent HIV infections for years.
Daniel O’Day, chairman and chief executive officer of Gilead Sciences, said Yeztugo is one of our most important scientific breakthroughs and offers a real opportunity to help end the HIV epidemic.
“This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention,” he said.
“Gilead scientists have made it their life’s work to end HIV, and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality.”
The World Health Organisation (WHO) welcomed the US FDA’s approval, describing it as a “milestone”.
WHO currently recommends oral PrEP, the dapivirine vaginal ring, and long-acting injectable cabotegravir (CAB-LA) as options for HIV pre-exposure prophylaxis (PrEP).
Meg Doherty, director of WHO’s global HIV, hepatitis and STI programmes, said Lenacapavir’s discreet, long-acting formulation may help overcome key barriers such as daily pill burden, frequent clinic visits, and stigma associated with HIV prevention.
“This regulatory milestone brings us one step closer to expanding access to an innovative HIV prevention option in lenacapavir,” Doherty said.
“WHO plays a key role in supporting countries through guideline development, prequalification, and regulatory processes. We are working with partners and national authorities to ensure lenacapavir reaches people who need it most – quickly, safely and equitably.”
