Lenacapavir, to be marketed as Yeztugo, could “redefine the PReP market,” according to analysts.
The FDA approved Gilead’s landmark long-acting HIV treatment lenacapavir Wednesday afternoon. The drug will be marketed under the name Yeztugo.
Lenacapavir had already been approved in 2022 and sold under a different name, Sunlenca. That approval only applied to patients with treatment-resistant HIV and had received prior treatment. Yeztuga is approved for all HIV patients as pre-exposure prophylaxis (PReP). Unlike previous generations of HIV medications like Gilead’s own once-daily Truvada, Yeztugo only is administered just once every six months.
BMO Capital Markets analysts see a smooth transition for Yetzugo into the clinic. “A clean label, strong clinical data, and a convenient twice yearly dosing regimen, in line with patient physician visits, should drive strong commercial adoption for Yeztugo in the long run,” they wrote in a note to investors after the news broke.
The drug “has the potential to ‘redefine’ the PrEP market,” Mizuho analysts wrote in their own note.
While effective, daily pills like Truvada have not curbed the global HIV epidemic significantly. In looking to develop a long-acting drug, Gilead pointed to the high frequency with which existing HIV preventive medications had to be taken as contributing to low uptake. The company also noted the social stigma related to taking HIV drugs and low patient awareness of PReP options as additional factors.
Yeztugo joins GSK and ViiV’s Aprectude as the only other long-acting PReP drug on the market. Aprectude got FDA approval to be administered every two months in 2021.
“This is a historic day in the decades-long fight against HIV,” Gilead CEO Daniel O’Day said in the company’s announcement. “Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic.”
The approval is based on data from two Phase III trials, PURPOSE I and PURPOSE II. In more than 2000 cisgender women tested in PURPOSE I, the drug achieved 100% prevention of HIV transmission, according to Gilead. In PURPOSE II, across more than 2000 cisgender men and gender-diverse people, there were two HIV infections, a 99.9% effectiveness rate at preventing new infections.
The drug was well-tolerated with no new significant safety issues reported in the PURPOSE trials.
The approval is a huge win for an HIV prevention sector that has been beleaguered by Trump administration cuts to research budgets. Of 770 canceled NIH grants, nearly 30% of them had to do with research on HIV treatment or cures.
