Merck’s doravirine/islatravir NDA in HIV-1 accepted by FDA

Merck (MRK) announced that the FDA has accepted for review the New Drug Application, or NDA, for doravirine/islatravir, or DOR/ISL, an investigational, once-daily, oral, two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy. The FDA has set a target action date of April 28, 2026, for the application under the Prescription Drug User Fee Act. The NDA is based on findings at Week 48 of two pivotal Phase 3 clinical trials where DOR/ISL was demonstrated to be non-inferior to baseline antiretroviral therapy and non-inferior to bictegravir/emtrictabine/tenofovir alafenamidei. Across both trials, the safety profile of DOR/ISL was generally comparable to comparator baseline antiretroviral regimens.