Merck Shared Topline Results From Phase 3 Trial Of An Oral, Two-drug, Single-tablet Regimen Of Doravirine/Islatravir In Adults With HIV-1 Infection Who Had Not Previously Received Antiretroviral Treatment (Treatment-naïve) (MK-8591A-053)

Author: Benzinga Newsdesk | November 19, 2025 06:48am

The company is planning to present detailed findings from this trial at a future scientific congress and to submit applications including these data to health authorities. The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for DOR/ISL for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen and has set a target action date of April 28, 2026, for the application under the Prescription Drug User Fee Act (PDUFA). In the U.S., doravirine is approved for the treatment of adults with HIV-1 in combination with other antiretrovirals as a single agent (PIFELTRO) and a component of a single-tablet regimen [DELSTRIGO; doravirine, lamivudine, and tenofovir disoproxil fumarate (DOR/3TC/TDF)]. 

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