Gilead Resubmitted New Drug Application for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitorto U.S. Food and Drug Administration

On June 27, 2022,- Gilead Sciences, Inc. announced the resubmission of the New Drug Application (NDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, to the U.S. Food and Drug Administration for the treatment of HIV-1 infection in profoundly treatment-experienced (HTE) people having multi-drug resistant (MDR) HIV-1 infection.

Gilead resubmitted the NDA as a response to the FDA Complete Response Letter (CRL) that was issued in February 2022, citing Chemistry Manufacturing and Controls (CMC) issues concerning the compatibility of lenacapavir in borosilicate vials as the cause for the FDA action. The NDA resubmission comprises all-inclusive CMC data to aid the compatibility of lenacapavir with an alternate vial type manufactured from aluminosilicate glass. Additionally, the NDA is reinforced by wide-ranging pre-clinical and prior clinical research data along with data from the Phase 2/3 CAPELLA study, which assessed the lenacapavir’santiviral activity administered every six months in the form of subcutaneous injection, in amalgamation with another antiretroviral (s), in severely treatment-experienced people having multi-drug resistant HIV-1 infection.

If approved by the FDA, a novel Prescription Drug User Fee Act (PDUFA) date would be established. According to Jared Baeten, the Vice President of the HIV Clinical Development of Gilead Sciences, there are people with HIV who have strictly limited treatment options owing to resistance to multiple antiretroviral therapy classes, and Gilead is committed to addressing the unmet needs and identifying the urgency for filling the critical treatment gap in cases of multi-drug resistant HIV where the virus is no longer effectuallyretorting to current therapy.