07:21 AM EDT, 07/10/2025 (MT Newswires) -- Merck ( MRK ) said Thursday the US Food and Drug Administration has accepted for review the new drug application for doravirine/islatravir, intended for adults with a certain HIV-1 infection.
The FDA has set a target action date of April 28, 2026.
The application is based on findings of two phase 3 studies which showed that doravirine/islatravir was non-inferior and its safety profile was generally comparable to baseline antiretroviral therapy and bictegravir/emtrictabine/tenofovir alafenamidei.