Merck said on Monday that it has requested authorization from the Food and Drug Administration (FDA) for its antiviral coronavirus 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.
Big picture: 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.
The price tag could also pose a challenge: The U.S. bought those 1.7 million courses of treatment for $700 each, and the price could change going forward once the treatment is authorized.
AstraZeneca says COVID-19 drug helps cut risk of severe disease, death
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AstraZeneca announced on Monday that its experimental COVID-19 treatment has been found to be effective in late-stage trials at preventing severe illness or death.
When compared to a placebo, AstraZeneca’s antibody treatment, called AZD7442, reduced the risk of developing severe COVID-19 or death by 67 percent, the company said in a press release.
“These important results for AZD7442, our long-acting antibody combination, add to the growing body of evidence for use of this therapy in both prevention and treatment of COVID-19,” Mene Pangalos, AstraZeneca’s executive vice president, said.
“An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months,” Pangalos added.
AstraZeneca said AZD7442 had been shown to prevent COVID-19 viruses from binding to host cells and was able to neutralize COVID-19 variants including the delta and mu strains.
Last week: AstraZeneca applied for an emergency use authorization for the preventative treatment, citing data from a trial showing that AZD7442 was 77 percent effective at stopping symptomatic cases of COVID-19.
The U.K.-based drugmaker has said discussions for setting up a supply agreement with the U.S. are “ongoing.”