FDA panel backs molnupiravir- first at-home COVID-19 pill

USA: The Food and Drug Administration's (FDA's) antimicrobial drugs advisory committee has concluded that potential benefits of Merck's molnupiravir outweighed risks to patients who were at risk for developing severe COVID-19. The decision was taken by majority voting in favour.Several members of the advisory group opined that the treatment should be used in older patients or those with significant underlying medical conditions that put them at high-risk for COVID-19 complications.

Earlier this month, the United Kingdom authorized use of the pill, excluding pregnant and breastfeeding women.

The drug, if authorized, would be the first at-home treatment for the virus after two years into the pandemic. The authorization would be limited to patients at high risk of developing severe disease. Merck's molnupiravir is the first pill indicated to treat COVID-19 infections and prevent hospitalization and death. It has been found that if molnupiravir is taken within the first 5 days of infection it leads to a 30% reduction in the risk of hospitalization and death. After authorization by FDA, molnupiravir would be the first antiviral agent available as a pill to treat COVID-19 besides monoclonal antibodies and remdesivir.

The data by Merck suggested that the drug was significantly less effective than previously thought, reducing death and hospitalizations in its clinical trial of high-risk people 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."

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 part of the virus called the RNA polymerase that has not been changed much by mutations in the Omicron variant. The pill - and a potentially more promising drug being developed by Pfizer - could become even more vital if vaccine-induced and natural immunity are threatened by the variant.