- Robert Preidt and Robin Foster
- Posted October 12, 2021
Merck Asks FDA to Approve First COVID Antiviral Pill
Merck & Co. announced Monday that it had submitted an application with the U.S. Food and Drug Administration for emergency use approval of the first antiviral pill targeted to COVID-19.
Experts say authorization of molnupiravir, at this time only for use inhigh-risk Americans, could be a major advance in the struggle against COVID-19 because a convenient, more affordable treatment could reach many more high-risk patients than the more complicated monoclonal antibody treatments now used, according to The New York Times.
"The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data," Merck CEO and President Robert Davis, said in a company statement announcing the application. "We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible."
The Biden administration has already placed an advance order for enough of the drug to treat 1.7 million Americans, at a cost of about $700 per patient, which is about one-third the price of antibody treatments typically given intravenously, the Times reported.
Merck expects to be able to produce enough molnupiravir for 10 million people by the end of the year, the Times reported.
As was the case with vaccines, the federal government is likely to ship the pills to states, which would then decide how to distribute them to patients, according to senior White House officials.
In clinical trials, the Merck pill halved hospitalizations among unvaccinated high-risk adults who started showing COVID-19 symptoms within the previous five days, the Times reported.
People would use molnupiravir at home and take four capsules twice a day for five days. A company spokesman told the Times that it would be up to the FDA to decide whether the treatment would be available to vaccinated people, who were not eligible for the clinical trial.
Pfizer and Atea Pharmaceuticals-Roche are also developing antiviral pills for COVID-19, the Times reported.
Visit the U.S. Centers for Disease Control and Prevention for more on COVID treatments.
SOURCE: The New York Times; Oct. 11, 2021, statement, Merck & Co.