Merck Seeks FDA Emergency Approval of Anti-COVID Pill
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.
The pill, which was developed in partnership with Ridgeback Biotherapeutics, targets the enzyme that allows the COVID-19 virus to make copies of itself. Merck has said the treatment is likely effective against variants of the virus, including the highly transmissible delta variant.
Merck already has agreements to sell the pills in several countries, including the U.S., Singapore, South Korea, Thailand and Australia.
The U.S. government is set to receive about 1.7 million courses of molnupiravir if it is granted emergency use authorization from the FDA. The company expects to produce 10 million courses of treatment by year’s end.
Former FDA Commissioner Scott Gottlieb has predicted that the FDA approval of antiviral pills as well as the approval of COVID-19 vaccines for children under 12 would likely bring about the end of the “pandemic phase” of COVID-19.
