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The British Medicines and Healthcare Products Administration (MHRA) has approved Merck’s molnupiravir for the treatment of adult patients with mild to moderate COVID-19 who have a positive SARS-CoV-2 diagnostic test and have at least one risk factor for serious disease
.
Merck said the US FDA is reviewing the emergency use authorization (EUA) application for molnupiravir
Molnupiravir (MK-4482, EIDD-2801) is a potent oral ribonucleoside analog that inhibits the replication of SARS-CoV-2.
This drug is the first oral antiviral drug approved for the treatment of COVID-19
.
The approval is based on the positive results of the interim analysis of the Phase 3 MOVe-OUT clinical trial
.
The MOVe-OUT trial (MK-4482-002) (NCT04575597) is a global phase 3, randomized, placebo-controlled, double-blind, multi-center study.