UK Becomes First Country to Approve Merck's Oral Antiviral Drug Molnupiravir for COVID-19
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Medicines and Healthcare products Regulatory Agency
The MHRA is an executive agency of the UK Department of Health and Social Care, responsible for ensuring that medicines and medical devices work effectively and are safe and reliable. Established in 2003 through the merger of the Medicines Control Agency and the Medical Devices Agency, the organization employs more than 1,300 staff members.
UK Medicines andHealth supplementsOn the 4th, the regulatory authority announced that it has approved molnupiravir, an oral anti-COVID-19 drug developed by Merck & Co., for use in certain COVID-19 patients. This marks the world's first oral anti-COVID-19 medication to be commercially available globally.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced in a press release on the 4th that molnupiravir has been approved for patients with mild to moderate COVID-19 who have at least one risk factor for progression to severe illness, including obesity, age over 60,Diabetes mellitusand heart disease, etc.
Molnupiravir, jointly developed by Merck & Co. and Ridgeback Biotherapeutics LP in the United States, is a small-molecule broad-spectrum oral antiviral drug targeting RNA viruses, capable of inhibiting the replication of SARS-CoV-2. The Phase III announced by Merck & Co. in early OctoberClinical TrialInterim analysis data show that the drug reduces the risk of hospitalization or death by approximately 50% in patients with mild-to-moderate COVID-19.
The press release stated that the UK regulatory authority and the government’s independent expert advisory group, the Commission on Human Medicines, conducted a rigorous review of its safety, quality, and efficacy, making it the first approved oral antiviral drug for the treatment of COVID-19 infection. Citing UK Health Secretary Sajid Javid, the release noted that approving the drug would be a "game-changer" for the most vulnerable and immunocompromised patients, who will soon have access to this breakthrough treatment.
The United Kingdom is the first country in the world to formally approve the use of molnupiravir for the treatment of COVID-19 patients. On October 5, the European Medicines Agency stated that it would consider initiating an accelerated assessment for molnupiravir. In October, Merck submitted an Emergency Use Authorization application for the drug to the U.S. Food and Drug Administration. (BioonBioon.com）