US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that the New Drug Application (NDA) for its lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP), has been accepted by the US Food and Drug Administration (FDA) for priority review. The Prescription Drug User Fee Act (PDUFA) target action date is set for June 19, 2025.
Drug Profile
Lenacapavir is a long-acting HIV-1 capsid inhibitor administered via injection twice a year. It is already approved in multiple countries for treating adults with multi-drug resistant HIV when used in combination with other antiretrovirals.
Clinical Trial Results
The NDA is supported by data from the Phase III PURPOSE 1 and PURPOSE 2 studies:
- PURPOSE 1: Zero infections were reported in the lenacapavir group, demonstrating 100% risk reduction and superiority compared to background HIV incidence (bHIV) in cisgender women.
- PURPOSE 2: Among cisgender men and gender-diverse participants, 99.9% in the lenacapavir group did not acquire HIV, showing a 96% risk reduction and superiority over bHIV.
In both trials, lenacapavir outperformed once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in preventing HIV infections.
Future Outlook
The FDA’s priority review designation, granted in October 2024, reflects the potential of lenacapavir to address unmet needs in HIV prevention. If approved, it will offer a new, long-acting option for PrEP.-Fineline Info & Tech
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