Posted by Michael Wonder on 31 Jul 2022
Gilead Sciences statement on FDA acceptance of new drug application for investigational lenacapavir
27 July 2022 - Gilead Sciences today announced that the U.S. FDA accepted for review the new drug application resubmission for 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 FDA has assigned a Prescription Drug User Fee Act action date of 27 December 2022.
