A Day After Pfizer's, US Approves Merck's COVID-19 Pill for High-Risk Adults

The United States Food and Drug Administration (FDA) on Thursday, 23 December, granted emergency use authorisation to Merck's pill for the treatment of COVID-19 in high-risk adults.

The pill, molnupiravir, is to be used 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 hospitalisation or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate," as per the FDA.

Molnupiravir is not authorized for use in patients younger than 18 years of age, because it may affect bone and cartilage growth in the younger population.

“Today’s authorization provides an additional treatment option against the COVID-19 virus in the form of a pill that can be taken orally. 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.”

Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research

The approval comes a day after the FDA granted emergency use authorisation to Pfizer's oral treatment, Paxlovid.

Paxlovid, the first treatment for COVID-19 that is in the form of a pill that is taken orally, is intended for the treatment of mild-to-moderate coronavirus disease in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds), who are at high risk for progression to severe COVID-19, including hospitalisation or death.