The United Kingdom has authorized the first oral medicine for COVID-19
Produced by Merck & Co (MSD) and Ridgeback Biotherapeutics, Molnupiravir will trade as Lagevior in the UK.
The first oral Covid-19 medicine, Molnupiravir, for treatment of mild to moderate Covid-19 in adults, who have at least one risk factor for developing severe illness has been authorized by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
“The first global authorization of Molnupiravir is a major achievement in MSD’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges,” says Robert M Davis, chief executive officer and president, MSD.
“As an oral therapeutic, Molnupiravir offers an important addition to the vaccines and medicines deployed so far to counter the Covid-19 pandemic,” says Dr. Dean Y. Li, executive vice president and president, MSD Research Laboratories.
Phase 3 MOVe-OUT clinical trial
The authorization is based on positive results from a planned interim analysis from 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-site study of non-hospitalized adult patients with laboratory-confirmed mild-to-moderate Covid
Patients enrolled in the study were unvaccinated against SARS-CoV-2, had at least one risk factor associated with poor disease outcomes, and symptom onset within five days prior to randomization.
The primary efficacy objective of MOVe-OUT is to evaluate the efficacy of molnupiravir compared to placebo as assessed by the percentage of participants who are hospitalized and/or die from the time of randomization through Day 29.
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