Forbes By Robert Hart | Forbes Staff
Key Facts
- Merck said it had asked the U.S. Food and Drug Administration for Emergency Use Authorization for an oral antiviral pill, Molnupiravir, to treat recently diagnosed patients at risk of severe illness.
- Merck said it is seeking authorization to use the pill to treat people with mild-to-moderate Covid-19 who are at risk of severe illness or hospitalization.
- Merck halted its late-stage study of the drug in early October based on very promising interim findings, a move the FDA endorsed and had been recommended by an independent group of experts monitoring the trial.
- If approved, Molnupiravir will become the first antiviral pill to treat Covid-19 on the market (all other antivirals authorized for use in the U.S. must be injected or delivered intravenously).
Key Background
Most Covid-19 treatments are expensive and recommended for use in hospitalized patients. Those that are recommended for use in patients outside of hospital are of limited use for patients without serious illness. These monoclonal antibody treatments are in short supply—so short that they are being rationed and are being reserved for the most serious cases in most states—and must usually be administered intravenously in a hospital setting anyway. Pills could be a pandemic gamechanger and help ease the burden on overwhelmed hospitals. They are relatively cheap to make, easier to manufacture and distribute and can be readily taken at home without medical supervision.
What To Watch For
There are several other oral antivirals in late-stage development for use against Covid-19. Pfizer is testing one to treat or prevent Covid-19, as is Swiss pharma giant Roche, alongside Boston-based Atea Pharmaceuticals. All companies expect trial results later this year which, if promising, may form the basis of an emergency use application.
Big Number
1.7 million. That’s how many five-day treatment courses of Molnupiravir the U.S. has bought. Former FDA commissioner and Pfizer board member Scott Gottlieb said this is “not enough,” pointing to the 50-80 million therapy courses stockpiled in preparation of a flu pandemic.
FURTHER READING
When Will We Have A Pill To Treat Covid? Here Are Three Antiviral Drugs Being Tested (Forbes)
Merck Says Its Antiviral Pill Cuts Risk Of Covid Hospitalizations, Deaths By Half (Forbes)
Antiviral pill: How close are we to a drug to treat Covid? (Financial Times)
How antiviral pill molnupiravir shot ahead in the COVID drug hunt (Nature)
