Merck seeks FDA approval for COVID-19 antiviralPill
A pill against Covid-19, developed by the pharmaceutical company Merck, was submitted for approval by U.S. authorities on Monday, bringing the world's arsenal against the pandemic with it a wholly new and simple-to-use weapon for the first time.
Merck said it has applied to the Food and Drug Administration (FDA) to approve its antiviral COVID-19 tablet.
According to Merck, emergency use permission was sought "for the treatment of mild-to-moderate COVID-19 in individuals who are at risk of escalating to severe COVID-19 and/or hospitalization."
The pharmaceutical firm said earlier this month that research revealed that molnupiravir, a five-day therapy developed in collaboration with Ridgeback Biotherapeutics, decreased the risk of hospitalization by 50%.
"The tremendous impact of this pandemic requires us to respond with unprecedented haste, and that is what our teams have done by submitting this application for molnupiravir to the FDA within ten days of receiving the data," Merck CEO and President Robert M. Davis said in a statement on Monday.
Merck claims that their tablet, which inhibits the enzyme that enables the COVID-19 virus to replicate, is likely effective against COVID-19 variations, including the highly contagious delta form.
The U.S. government already has a supply arrangement with Merck to purchase about 1.7 million courses of molnupiravir if the FDA grants emergency use permission.
Merck has already committed to market the tablets in Singapore, South Korea, Thailand, and Australia.
"We are thankful to the clinical investigators and patients who have assisted us in reaching this significant milestone."
Today's accomplishment would not be possible without their substantial efforts, "Ridgeback Biotherapeutics CEO Wendy Holman announced the news on Monday.
"The FDA application is an important step toward making molnupiravir accessible to individuals who may benefit from an oral antiviral medication that may be used at home soon after a COVID-19 diagnosis."
Molnupiravir has been described as a "game-changer" by former FDA Commissioner Scott Gottlieb.
He predicted last week that the "pandemic phase" of COVID-19 would likely end with the licensing of antiviral tablets and COVID-19 vaccinations for children under the age of 12.
However, he also said that 1.7 million courses of the medication would be insufficient and that rationing would be necessary.
President Biden's top medical advisor, Anthony Fauci, said earlier this month that it is a "false narrative" to believe that COVID-19 vaccinations would be unnecessary if the FDA authorizes Merck's antiviral COVID-19 therapy.
Fauci said on ABC's This Week, "Remember, the easiest way to stay out of the hospital, and not die, is don't get infected. I mean, this idea about 'We have a drug, don't get vaccinated,' just doesn't make any sense."
Merck files oral Covid-19 pill with FDA for emergency use nod