Gilead Submits NDA for HIV Therapy Lenacapavir

Gilead Sciences has submitted a New Drug Application (NDA) to the FDA seeking approval of lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treated people with multi-drug resistant (MDR) HIV-1 infection.

The submission is supported by data from the phase 2/3 CAPELLA trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously every six months in combination with an optimized antiretroviral background regimen. Data on lenacapavir will be presented during the 11th International AIDS Society Conference on HIV Science in July 2021.

Gilead reported in March updated data from CAPELLA that found that lenacapavir maintained viral suppression in heavily pretreated patients through week 26. This builds on data reported in November 2020 that lenacapavir achieved its primary endpoint by demonstrating that a significantly higher proportion of participants achieved a clinically meaningful viral load reduction in heavily treated people with multidrug resistant HIV-1 infection.

In the study, 36 participants with multi-class HIV-1 drug resistance and a detectable viral load while on a failing regimen were randomly allocated to receive oral lenacapavir or placebo for 14 days, in addition to continuing their failing regimen (functional monotherapy). An additional 36 participants were enrolled in a separate treatment cohort.

In May 2019, the FDA granted Breakthrough Therapy designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients.

Gilead and Merck in March announced that the two companies will develop and commercialize the combination of lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, for the treatment of HIV. The first clinical studies of the oral combination are expected to begin in the second half of 2021.