FDA Accepts Merck's New Drug Application for Doravirine/Islatravir, Setting April 2026 Decision Date
Merck & Co. Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its investigational HIV treatment, doravirine/islatravir (DOR/ISL). This once-daily, oral, two-drug regimen is designed for adults with HIV-1 infection who are virologically suppressed on antiretroviral therapy. The FDA has set a target action date of April 28, 2026, under the Prescription Drug User Fee Act. If approved, DOR/ISL would be the first FDA-approved two-drug regimen without an integrase inhibitor, offering a non-inferior efficacy and safety profile compared to current three-drug regimens. The NDA is supported by data from two Phase 3 clinical trials demonstrating its effectiveness and safety.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Merck & Co. Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250710518672) on July 10, 2025, and is solely responsible for the information contained therein.
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