Merck submits emergency use authorization for COVID-19 pill
The pill is for adults who are at risk for progressing to severe COVID-19 and/or hospitalization.
Photo: Anton Petrus/Getty Images
Merck has submitted an Emergency Use Authorization application to the U.S. Food and Drug Administration for molnupiravir, an oral antiviral medicine for the treatment of mild-to-moderate COVID-19.
The pill is for adults who are at risk for progressing to severe COVID-19 and/or hospitalization.
Merck reported positive results from a clinical trial that evaluated molnupiravir in nonhospitalized adult patients. Ten days after receiving the data, Merck submitted its application to the FDA, according to CEO and President Robert M. Davis.
Merck and Ridgeback Biotherapeutics, a biotechnology company, said they are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months.
WHY THIS MATTERS
The pill represents another drug to treat COVID-19 and to keep patients from getting more severely ill and from needing hospitalization.
The number of COVID-19 cases, hospitalizations and deaths are again declining in the United States, according to data from the Centers for Disease Control and Prevention, though last week the country hit the grim milestone of surpassing 700,000 deaths from COVID-19.
While the number of cases is trending in the right direction, many hospitals are reportedly still struggling through a large caseload due to the Delta variant and staffing shortages. Burnout, and to a lesser extent, vaccine mandates, are causing healthcare workers to leave their positions.
Health systems and hospitals are paying $24 billion more this year than pre-pandemic for clinical labor, according to a Premier report.
THE LARGER TREND
Vaccination remains the frontline defense against COVID-19.
Over half of Americans, 56.4%, have been fully vaccinated, according to the CDC. More than 65% have gotten one dose.
Shares of stock for COVID-19 vaccine makers dropped Friday morning after Merck announced it was seeking regulatory approval for the pill, according to Forbes.
Earlier this year, Merck entered into a procurement agreement with the U.S. Government under which the company will supply approximately 1.7 million courses of molnupiravir to the U.S. Government, upon EUA or approval from the U.S. FDA.
Additionally, Merck has entered into supply and advance purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with additional governments.
Merck previously announced that the company has entered into nonexclusive voluntary licensing agreements for molnupiravir with established Indian generic manufacturers to accelerate the availability of molnupiravir in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com
