Gilead chases TGA approval for twice-a-year HIV PrEP injection after FDA says yes
This week’s US Food and Drug Administration decision was the world’s first approval for HIV pre-exposure prophylaxis in an injectable form.
The US drug watchdog has approved a world-first biannual HIV pre-exposure prophylaxis injection, and the manufacturer has already lodged a TGA application.
Gilead’s HIV-1 capsid inhibitor lenacapavir (Yeztugo) is 99.9% successful in preventing HIV infections, the company says, based on results from its PURPOSE trials.
The TGA approved a lenacapavir pill for multidrug-resistant HIV in 2023 under the brand name Sunlenca.
However, this week’s US Food and Drug Administration (FDA) decision was the world’s first approval for injectable lenacapavir for long-term pre-exposure prophylaxis (PrEP).
