The Merck and Ridgeback Biotherapeutics’ oral antiviral, molnupiravir, was authorized by the UK Medicines and Healthcare Products Regulatory Agency on Thursday for treatment of mild and moderate Covid-19 cases. This is the first antiviral oral drug to be authorized for the treatment of Covid-19 and is authorized for adults at risk for severe illness. The US Food and Drug Administration said it will hold an Antimicrobial Drugs Advisory Committee to discuss molnupiravir’s ability to be authorized in the United States. The European Medicines Agency has initiated a review of its marketing application.
The capsule was announced to reduce the risk of hospitalization or death from Covid-19 by 50%. 7.3% of patients treated with molnupiravir were hospitalized or died from Covid-19 after Day 29 of the trial. This compares to 14.1% of patients treated with the placebo who died or who were hospitalized. The data has not been reviewed, but revealed potential for an easily accessible treatment for Covid-19. The antiviral remdesivir is the only other drug approved by the FDA for treatment of Covid-19 and is administered through intravenous infusion and does not work for all Covid-19 patients. The creators of molnupiravir will not receive royalties for the sales of the antiviral drug while Covid-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.