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What’s Taking the FDA So Long on COVID Drug Molnupiravir?

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Director at Public Health and American Well-Being Initiative
Joel M. Zinberg, M.D., J.D. is the Director of the Public Health and American Well-Being Initiative at Paragon Health Institute, and a senior fellow with the Competitive Enterprise Institute. A native New Yorker, he recently completed two years as General Counsel and Senior Economist at the Council of Economic Advisers in the Executive Office of the President.

On October 1, pharmaceutical companies Merck and Ridgeback Biotherapeutics announced that their investigational oral antiviral drug Molnupiravir reduced the risk of hospitalization or death by about 50 percent compared with placebo for patients with mild or moderate COVID-19. Now the breakthrough drug from the two American companies has been approved — in the United Kingdom. Americans will have to wait at least a month more.

The drug is so exciting because it will be the first effective antiviral pill against COVID-19. Remdesivir, the only FDA-approved antiviral for COVID-19, must be administered intravenously in a hospital or in a similar medical setting, making it much more cumbersome and expensive to utilize. Monoclonal antibody treatments are expensive, hard to manufacture, and must also be administered intravenously. Molnupiravir would be the first treatment that patients could take at home.

To continue reading, go to the original article at National Review.

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