Merck requests FDA authorization for COVID-19 antiviral pill
Merck said on Monday that it has requested authorization from the Food and Drug Administration (FDA) for its antiviral COVID-19 pill.
Merck said in a statement that an emergency use 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 pharmaceutical company said earlier this month that testing showed that molnupiravir, which is administered as a five-day treatment and was developed with Ridgeback Biotherapeutics, reduced the risk of hospitalization by 50 percent.
“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,” Robert M. Davis, CEO and president of Merck, said in a statement on Monday.
Merck has said that its pill, which targets the enzyme that allows the COVID-19 virus to make copies of itself, is likely effective against COVID-19 variants, including the highly infectious delta variant.
The U.S. government already has a supply agreement with Merck to acquire about 1.7 million courses of molnupiravir if it receives emergency use authorization from the FDA.
Merck has already agreed to sell the pills to countries like Singapore, South Korea, Thailand and Australia.
“We are grateful to the clinical investigators and patients who have helped bring us to this important milestone. Without their significant contributions, today’s achievement would not be possible,” Ridgeback Biotherapeutics CEO Wendy Holman said in a statement on Monday. “The submission to the FDA is a critical step towards making molnupiravir available to people who may benefit from an oral antiviral medicine that can be taken at home shortly after diagnosis with COVID-19.”
Former FDA Commissioner Scott Gottlieb has referred to molnupiravir as a “game changer.” He predicted last week that the “pandemic phase” of COVID-19 would likely come to an end with the approval of antiviral pills as well as the approval of COVID-19 vaccines for children under 12.
However, he also said that 1.7 million courses of the medicine would not be enough and said rationing would be likely.
Earlier this month, President Biden’s top medical adviser, Anthony Fauci, said that it is a “false narrative” to think that COVID-19 vaccines would not be needed if Merck’s antiviral COVID-19 treatment is federally approved.
“Remember, the easiest way to stay out of the hospital, and not die, is don’t get infected,” Fauci said on ABC’s “This Week.”
“I mean, this idea about ‘We have a drug, don’t get vaccinated,’ just doesn’t make any sense,” Fauci added.
–Updated at 7:33 a.m.