US grants emergency use authorization for Merck's COVID-19 pill
Dec 23, 2021
Washington [US], December 23 : The US Food and Drug Administration (FDA) on Thursday said that it has granted an emergency use authorization for Merck's antiviral pill Molnupiravir that is used to treat COVID-19 patients.
"Today, the US Food and Drug Administration issued an emergency use authorization (EUA) for Merck's Molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate," the FDA said in a statement.
Molnupiravir is available by prescription only and should be initiated as soon as possible after COVID-19 diagnosis and within five days of symptom onset, the statement said.
The FDA pointed out that it did not authorize the use of Molnupiravir for patients younger than 18 due to potential negative effect on bone and cartilage growth. Nor can the medication be used for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19, the US agency said.
"Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death," FDA Center for Drug Evaluation and Research Director Patrizia Cavazzoni said in the statement.
The granting of the emergency use authorization is a crucial step in expanding the US arsenal of therapies for COVID-19, Cavazzoni added.
