Posted by Michael Wonder on 29 Jun 2021
Gilead submits new drug application to U.S. FDA for lenacapavir, an investigational, long-acting capsid inhibitor for the treatment of HIV-1 in people with limited therapy options
28 June 2021 - If approved, lenacapavir would be the first capsid inhibitor and the only HIV-1 treatment option administered every 6 months.
Gilead Sciences announced today that the company completed submission of a new drug application to the U.S. FDA seeking approval of lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment experienced people with multi-drug resistant 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 optimised antiretroviral background regimen.
