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Merck Says FDA Accepts for Review New Drug Application for Doravirine/Islatravir to Treat HIV-1 Infection in Adults
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Merck Says FDA Accepts for Review New Drug Application for Doravirine/Islatravir to Treat HIV-1 Infection in Adults
Jul 10, 2025 4:50 AM

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.

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