UK Approves Merck’s COVID-19 Antiviral Pill
November 8, 2021
Last Thursday, the UK became the first country to approve an antiviral drug for COVID-19. Molnupiravir, developed by Merck and Ridgeback Biotherapeutics, is designed to stop SARS-CoV-2 from replicating by disrupting its genetic code. It can be taken orally from home to treat mild to moderate symptoms. Trial research shows that the pill is most effective when taken early into a COVID-19 infection, within the first five days of experiencing symptoms.
In October 2020, Merck started a Phase 2/3 safety and efficacy trial in patients hospitalized with COVID-19. While using Molnupiravir in hospitalized patients did not show promising results, another trial showed that high-risk participants who took Molnupiravir at home, upon onset of symptoms, were 50% less likely to be hospitalized or die. In the clinical trial, the most common risk factors for severe COVID-19 included being 60+ years of age, being obese, or having diabetes.
Data around Molnupiravir was assessed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Britain. Merck submitted its application for Molnupiravir to the FDA on October 11.