The U.S. Food and Drug Administration will consider an emergency use authorization application for a pill that aims to treat mild-to-moderate COVID-19 in adults who are at risk of the sickness progressing into severe illness.
On Monday, Oct. 11, the pharmaceutical company Merck announced it had submitted its application for an EUA for its oral antiviral medication, molnupiravir. The move came 10 days after Merck announced its clinical trials were successful in reducing hospitalization and death from COVID-19 by 50%.
The FDA’s advisory committee of independent medical experts is likely to meet later this year to review the data and come up with its recommendation for federal regulators. A date for that meeting of the Vaccines and Related Biological Products Advisory Committee hasn’t been announced.
“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, Merck’s chief executive officer and president, in a prepared statement.
During clinical trials, no volunteers who received the drug after testing positive for coronavirus died of COVID-19, compared to eight individuals who received a placebo, according to the company. The incidences of adverse events from COVID-19 and/or from the drug itself were comparable between those who got the placebo and those who received molnupiravir.
Merck’s request for EUA would be for adults with mild-to-moderate COVID-19, who are at risk for progressing to severe COVID-19 and/or hospitalization. It’s unclear what other eligibility requirements would be considered if approved.
Molnupiravir is a form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, which causes COVID-19. Health officials say it isn’t meant to replace vaccines, but rather to provide another treatment option for those who become infected with coronavirus.
In addition to potentially being used to treat COVID-19, the drug is also being evaluated in clinical trials to determine if it could be safe and effective at preventing the spread of COVID-19 within households. Data from those trials hasn’t been made public.
More than 1.05 million Michigan residents have developed COVID-19 since the start of the coronavirus pandemic, including at least 21,313 residents who died.
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