New Drug Application re submitted to FDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor. - Gilead Sciences
Gilead Sciences, Inc. announced the resubmission of the New Drug Application (NDA) to the FDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.
Gilead resubmitted the NDA in response to the FDA Complete Response Letter (CRL) issued in February 2022, which cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir in borosilicate vials as the reason for the FDA action. The NDA resubmission contains comprehensive CMC data to support the compatibility of lenacapavir with an alternative vial type made from aluminosilicate glass.
In addition, the NDA is supported by extensive pre-clinical and earlier clinical research data as well as data from the Phase II/III CAPELLA study, which evaluated the antiviral activity of lenacapavir administered every six months as a subcutaneous injection, in combination with other antiretroviral(s), in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. Once accepted by the FDA, a new Prescription Drug User Fee Act (PDUFA) date will be established.
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