FDA Accepts Merck's Filing for Two-Drug, Once-Daily HIV Pill

Key Takeaways MRK's NDA for its two-drug HIV pill DOR/ISL has been accepted by the FDA, with a decision due in 2026. DOR/ISL showed non-inferiority to current HIV therapies in two pivotal phase III studies. MRK continues HIV research with additional trials and a collaboration with GILD on islatravir combinations.Merck (MRK) announced that the FDA has accepted for review the new drug application (“NDA”) seeking approval for its investigational, once-daily, oral, two-drug, single-tablet regimen of doravirin ...