FDA committee narrowly recommends Merck's antiviral pill to treat COVID-19
The drug decreases hospitalizations and deaths by 3%, which is not enough of a benefit to outweigh the risks, says one member.
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The FDA's Antimicrobial Drugs Advisory Committee voted 13-10 to recommend that the FDA authorize Merck's antiviral pill to treat COVID-19. Safety concerns include a recommendation that the drug not be used during pregnancy.
Many committee members said their vote was a difficult decision. Those who voted "yes" said the drug's benefits outweigh the risks, while those who rejected recommendation cited safety concerns, the need for more data and the lack of a benefit for those who have a mild to moderate case of the coronavirus.
"I voted no, because I was not convinced that the potential benefit of a 3% decrease in hospitalizations and deaths outweighed the known and potential risks of the post-treatment even under the protections of an EUA," said committee member Dr. Peter J. Weina.
On Nov. 26, Merck said the pill molnupiravir reduced the risk of hospitalization or death from 9.7% in the placebo group to 6.8% in the molnupiravir group, for an absolute risk reduction of 3%. Nine deaths were reported in the placebo group, and one in the molnupiravir group.
On Tuesday, the FDA Antimicrobial Drugs Advisory Committee voted to recommend to the FDA for emergency use authorization the oral antiviral medicine molnupiravir, for the treatment -- within five days of symptom onset -- of mild to moderate COVID-19 in adults who are at high risk for progressing to a severe case and/or hospitalization.
WHY THIS MATTERS
The pill developed by Merck and Ridgeback Biotherapeutics represents the first at-home treatment for COVID-19, should the FDA approve the pill.
"With the continued spread of the virus and the emergence of variants, additional treatments for COVID-19 are urgently needed," said Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, in a statement.
"We are one step closer to being able to add molnupiravir to the tools that we have – in addition to vaccines – that can be available and accessible to help fight COVID-19," said Wendy Holman, CEO of Ridgeback Biotherapeutics. "Importantly, our data show activity against the most prevalent variants today, and molnupiravir was studied as a monotherapy with no drug-drug interactions observed to date."
Merck expects to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022, according to Reuters. The U.S. government has a contract to buy as many as 5 million courses of the drug at a price of $700 per course, the report said.
Pfizer is also developing a similar drug.
THE LARGER TREND
Several committee members cited the need for such a drug as COVID-19 continues to be an emergency situation and the World Health Organization recently declared the Omicron variant "a variant of concern."
There are many unknowns to Omicron, including how effective current vaccines will be against the new variant. The FDA said it is investigating possible impacts of the Omicron variant as it urges vaccination and boosters.
Hospitals in the United States are again facing an increase in cases, with its resulting workforce burnout. This is adding to staffing and supply chain shortages and a strain on companies' revenue.
Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com
