Gilead wins approval for twice yearly HIV prevention shot
The approval, which was largely expected, stands to breathe life into Gilead’s HIV prevention business.
Gilead won approval from the Food and Drug Administration to market a twice yearly injection that prevents HIV in high-risk patients, potentially helping bring the AIDS pandemic to heel and cushioning the company’s revenues.
The shot, known chemically as lenacapavir, will be sold under the brand name Yeztugo. Currently the same drug is sold under the brand name Sunleca, which was initially approved to treat HIV in patients who are already positive.
The company was flat on the news, likely because the approval was largely expected. The approval stands to breathe life into Gilead’s HIV prevention business but faces headwinds as public health and international aid funding have been slashed by the Trump administration.
Gilead’s brands for PrEP — or pre-exposure prophylaxis, a type of drug that prevents HIV in high-risk patients — have grown less lucrative since its first-generation drug, Truvada, had its patent expire in 2020. Descovy, a newer and safer version of the same treatment, has become more popular but is sold at a lower price because of competition with Truvada’s generic alternative.
Both Truvada and Descovy are pills taken once daily. The only other injectable PrEP on the market — Apretude, sold by ViiV Healthcare — is administered every two months.
Five Gilead executives and board members, including CEO Daniel O’Day, bought stock on June 10.
