The European Medicines Agency (EMA) has started a rolling review of molnupiravir, the oral antiviral developed by Merck & Co – known as MSD outside the US and Canada – and partner Ridgeback Biotherapeutics for the treatment of COVID-19 in adults.
Data from laboratory and clinical studies will be evaluated by the Committee for Medicinal Products for Human Use (CHMP). If approved, molnupiravir would be the first oral antiviral for use against COVID-19 in Europe.
Merck’s drug is also being reviewed by the US Food and Drug Administration (FDA) and other regulatory agencies worldwide.
Many see an oral antiviral as an essential part of an effective medical toolkit against COVID-19. At present, Gilead’s Veklury (remdesivir) and Regeneron’s antibody cocktail REGEN-COV (Ronaprevein Europe) are being used to treat COVID-19, but only for people hospitalised with more severe disease as the drugs need to be administered intravenously.
“In the nearly two years since COVID-19 emerged, the global scientific community has made extraordinary strides in developing several critical vaccines and treatments, but we still have a need for an oral antiviral medicine that can be taken at home,” said Wendy Holman, CEO of Miami-based Ridgeback Biotherapeutics.
Earlier this year, Merck struck a deal with the US government to supply 1.7 million courses of molnupiravir following FDA approval. The company has entered into similar agreements with governments worldwide, including the UK government, which announced last week that it had ordered 480,000 courses of the antiviral in addition to 250,000 courses of Pfizer’s antiviral combination PF-07321332 and ritonavir.
The company has ramped up its manufacturing ahead of regulatory approval and expects to produce 10 million courses of the drug by the end of 2021.
These deals are based on data from the phase 3 MOVe-OUT clinical trial that studied molnupiravir in non-hospitalised adult patients with mild-to-moderate COVID-19 who were at increased risk for progressing to severe COVID-19 and/or hospitalisation.
An interim analysis showed that molnupiravir reduced the risk of hospitalisation or death by approximately 50% against placebo.
If approved, Merck has announced it will adopt a tiered pricing approach based on each country’s income and “relative ability to finance their health response to the pandemic”. It has previously announced non-exclusive voluntary licensing agreements with Indian generic manufacturers that will enable molnupiravir to be made available more quickly in more than 100 low- and middle-income countries (LMICs).