Lenacapavir submitted to the US FDA with an indication for HIV PrEP
20 December 2024. Related: Early access, Antiretrovirals, Treatment access, HIV prevention and transmission.
Simon Collins, HIV i-Base
On 19 December 2024, Gilead announced that it had submitted a new drug application to the US FDA for lenacapavir to be used as 6-monthly HIV PrEP. [1]
The submission is primarily based on the results from the two large randomised PURPOSE 1 and 2 phase 3 studies, that were recently reported in July and October at the IAS and R4P conferences respectively.
Both studies showed lenacapavir to be highly effective at preventing new HIV infections with 100% and 96% efficacy compared to control arms, with higher adherence driving superiority results compared to oral TDF/FTC.
The application has been granted Breakthrough Therapy Designation for a faster review. This also included rolling submission of new data as it becomes available, with the first results submitted at the end of November.
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Although the press release didn’t include a timeline, the breakthrough designation should enable a decision within six months. WHO generally depends on US approval before a drug can be included in the list of essential medicines.
A decision on the price in high-income countries is only usually announced after FDA approval.
The focus on approval in low- and middle-income settings will depend on international funders committing to ambitious programmes that will enable economies of scale.
Reference
- Gilead press release. Gilead Submits New Drug Application to U.S. Food and Drug Administration for Twice-Yearly Lenacapavir for HIV Prevention. (19 December 2024).
https://www.gilead.com/company/company-statements/2024/gilead-submits-new-drug-application-to-us-food-and-drug-administration-for-twice-yearly-lenacapavir-for-hiv-prevention