Posted by Michael Wonder on 01 Mar 2022
Gilead receives complete response letter from U.S. FDA for investigational lenacapavir due to vial compatability issues
1 March 2022 - Complete response letter cites issues related to compatibility of vials and lenacapavir solution.
Gilead Sciences today announced the U.S. FDA has issued a complete response letter for the new drug application for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor under review for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection.
