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

A breakthrough pill has been approved in the United Kingdom. Americans will have to wait at least a month more.

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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.

Molnupiravir was studied in 762 newly diagnosed, high-risk patients who had one or more risk factors for severe COVID-19 — they were either over 60 years old or had diabetes, obesity, or heart disease. Subjects who received the drug were half as likely to be hospitalized as those who had received placebo. While eight people in the placebo group died, none in the drug group did. Side effects were no more common with the drug than with placebo.

The study was stopped early, with the consent of the FDA, when an independent monitoring board concluded the drug was so effective that it would be unethical to continue giving placebo. An earlier study indicated that the drug may also decrease disease transmission by lowering the viral levels in the nasopharynx and clearing the virus more quickly.

The companies applied to the FDA for an emergency-use authorization (EUA). But the FDA announced on October 14 that it would convene an outside expert advisory committee — something it is not required to do — to consider the data supporting the use of Molnupiravir more than six weeks later, on November 30. Even if the committee were to render a decision immediately, FDA authorization would not occur until well into December.

Read the full article at National Review.