Merck Seeks FDA Emergency Approval of Anti-COVID Pill

Molnupiravir, an experimental coronavirus treatment pill developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, May 17, 2021 (Merck & Co Inc/Handout via Reuters)

Merck announced Monday that it has requested emergency use authorization from the Food and Drug Administration (FDA) for its experimental antiviral COVID-19 pill.

The drugmaker said in a statement that the authorization was requested “for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.”

The request comes after Merck said earlier this month that the drug, molnupiravir, which is a five-day treatment, reduced the risk of hospitalization by 50 percent. The drug would be the first pill shown to treat COVID-19, if it receives approval from the FDA. The agency could issue a decision in a matter of weeks. 

“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,” said Robert M. Davis, chief executive officer and president of Merck.

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