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WASHINGTON — A panel of expert advisers to the U.S. Food and Drug Administration on Tuesday narrowly voted to recommend the agency authorize Merck's antiviral pill to treat COVID-19.
If the FDA authorizes the drug, it would be the first at-home treatment for the virus nearly two years into the pandemic. The authorization would likely be limited to patients at high risk of developing severe disease, although the exact population would be defined by the agency.
Merck published data last week suggesting that the drug was significantly less effective than previously thought, reducing hospitalizations and deaths in its clinical trial of high-risk individuals by around 30%.
"COVID-19 is still an emergency situation," said committee member Dr. David Hardy, who voted yes. "There is a need for something like this. This is the first opportunity that an oral outpatient medication for mildly symptomatic to moderately symptomatic persons would be available, although I do have questions about its overall longer-term efficacy."
This is the first opportunity that an oral outpatient medication for mildly symptomatic to moderately symptomatic persons would be available, although I do have questions about its overall longer-term efficacy.
–Dr. David Hardy
The vote comes as fears about the new omicron variant have rattled financial markets and sparked concerns about the strength of the global economic recovery as the world continues to fight the coronavirus pandemic.
Merck's oral therapy called molnupiravir, developed with Ridgeback Biotherapeutics, targets parts of the virus that are not changed by mutations in the omicron variant. They could become even more vital if vaccine-induced and natural immunity are threatened by the variant.
A rival drug being developed by Pfizer, called Paxlovid, is particularly promising, having shown an 89% reduction in hospitalizations and deaths in its clinical trial. The FDA could consider that drug within the next few months.
The FDA's Antimicrobial Drugs Advisory Committee voted 13-10 to recommend the agency authorize the drug after discussing concerns that the drug could cause the virus to mutate as well as safety concerns about the potential for birth defects. Both FDA staff scientists and Merck have suggested the drug should not be recommended during pregnancy.
