The FDA issued a complete response letter (CRL) for the New Drug Application (NDA) for lenacapavir, an investigational, long-acting HIV-1 treatment for people with multidrug-resistant (MDR) HIV-1 infection.
Lenacapavir, a capsid inhibitor, is being developed by Gilead Sciences.
In the CRL, the FDA cited issues with Chemistry Manufacturing and Controls. The agency is concerned that the medication is not compatible with the proposed borosilicate glass vial, which contains boron trioxide to prevent