FDA accepts New Drug Application for Merck’s doravirine/islatravir, an investigational, once-daily, oral, two-drug regimen for treatment of adults with virologically suppressed HIV-1 infection
Merck announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application for doravirine/islatravir (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 (PDUFA).
Doravirine/islatravir would be the first FDA-approved two-drug regimen without an integrase inhibitor that demonstrated non-inferior efficacy and a generally comparable safety profile to the three-drug InSTI-based regimen, BIC/FTC/TAF, in a Phase 3 pivotal trial.
Read the full company press release here.
Source : Merck
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