Gilead Sciences, Inc. announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor under review for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.

In the CRL, the FDA has cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir with the proposed container vial as the reason for their action. As previously announced, FDA raised questions about vials made of borosilicate glass and their compatibility with lenacapavir solution, which has resulted in a clinical hold for injectable lenacapavir.

Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, said:

Gilead intends to provide FDA with a comprehensive plan and corresponding data to use a different vial type. We look forward to discussing this further with FDA over the coming months so that we can make this investigational new therapy available to people living with multidrug-resistant HIV as soon as possible. People living with multidrug-resistant HIV need new treatment options and we will continue to pursue approval of lenacapavir to offer a much-needed new long-acting treatment option for this population.

The lenacapavir NDA was submitted to the FDA for the treatment of heavily-treatment experienced people with multi-drug resistant HIV in June 2021 and selected for priority review due to the significant unmet need of this population. The submission was 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 in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. New clinical data on lenacapavir were presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022). The Week 52 findings from the CAPELLA trial demonstrated that lenacapavir, administered subcutaneously every six months in combination with other antiretrovirals, achieved high rates of virologic suppression and clinically meaningful increases in CD4 counts in people living with HIV whose virus was no longer effectively responding to their current therapy. In the CAPELLA study, the most common adverse events observed were injection site reactions (63%), nausea and diarrhea (13% each), and COVID-19 (11%).

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS.