Injectable HIV Prevention Drug Gets FDA Nod

Individuals at risk for sexually-acquired HIV have a new injectable option for preexposure prophylaxis (PrEP) with the US Food and Drug Administration’s (FDA’s) approval of lenacapavir, according to a press release from manufacturer, Gilead.

Lenacapavir, marketed as Yeztugo, is the first twice-yearly injectable to be indicated for PrEP for adults and adolescents weighing at least 35 kg (approximately 77 pounds).

Lenacapavir is administered via an injection into the subcutaneous layer of fat in the abdomen. The resulting “drug depot” may feel like a bump or nodule but resolves or shrinks before the next injection, according to the company. 

The approval was based on data from a pair of studies, PURPOSE 1 and PURPOSE 2. In the PURPOSE 1 study, published in The New England Journal of Medicine (NEJM), lenacapavir was 100% effective in preventing HIV infection compared to background HIV incidence in cisgender women and significantly more effective than daily oral combination therapy of emtricitabine and tenofovir disoproxil fumarate (Truvada). Notably, the study included pregnant women and adolescents, and the drug was generally well tolerated.

In the PURPOSE 2 study, also published in NEJM, lenacapavir was similarly effective for HIV infection prevention in a population of cisgender men and gender-diverse persons, with only two infections in the more than 2000 individuals randomized to lenacapavir. 

Overall, the injection was well tolerated but is contraindicated for individuals who test positive for HIV; a negative test is required before each injection, according to the company.

The specifics of cost and insurance coverage for lenacapavir remain to be seen, but Gilead’s Advancing Access medication assistance program will provide the drug at no cost to eligible patients, according to the press release.

Lenacapavir was granted Breakthrough Therapy Designation by the FDA in October 2024 and was approved under the FDA’s Priority Review process. Gilead has submitted a marketing authorization application with the European Medicines Agency and filed for regulatory approval in multiple countries worldwide including Australia, Brazil, Canada, and South Africa.

The PURPOSE 1 and 2 studies were funded by Gilead.