The US Food and Drug Administration (FDA) has approved Gilead Sciences' injectable product, Yeztugo (lenacapavir), as a pre-exposure prophylaxis (PrEP) against HIV.
It is the first and only biannual PrEP option available in the US for adults and adolescents weighing at least 35kg.
Yeztugo is a long-acting antiretroviral agent that provides sustained protection against HIV-1 infection.
Before starting treatment with Yeztugo, individuals must test negative for HIV-1. It is available as a tablet and a subcutaneous injection.
Gilead Sciences chairman and CEO Daniel O’Day stated: “This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very 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. 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 FDA approval is based on the outcomes from Phase III PURPOSE I and II trials demonstrating that more than 99.9% of participants who received Yeztugo remained HIV-negative.
Beyond the US market, Gilead has sought approvals globally, submitting applications within Europe, including a marketing authorisation application and an EU-Medicines for all (EU-M4all) application with the European Medicines Agency (EMA).
It is also pursuing authorisations in countries including Australia, Brazil, Canada and South Africa.
Following this latest approval from the FDA, additional filings are planned for countries including Argentina, Mexico and Peru.
No other international regulatory bodies have yet approved lenacapavir for HIV prevention.
The FDA recently implemented a clinical hold on several of Gilead's studies that are testing two potential HIV treatments, while the remainder of the company's extensive research portfolio continued without impact.
