Posted on December 01, 2021 in: Professional Practice
Expert advisers to the Food and Drug Administration recommended authorization Tuesday of the first coronavirus pill to prevent high-risk people from developing severe illness in a divided vote that reflects the complicated mix of benefits and risks involved with a new and easy mode of treatment.
Merck and Ridgeback Biotherapeutics developed the drug, molnupiravir, as a five-day regimen to be taken at home within five days of onset of coronavirus symptoms. The FDA is not bound by the 13-to-10 vote but typically follows its external advisers’ recommendations. The drug could have an immediate impact on the pandemic if authorized — just as the ominous new omicron variant has emerged, jolting the world with the prospect of a longer and more complicated pandemic.
Merck has pledged to manufacture treatment courses for 10 million patients by the end of the year, and the United States has preordered enough medicine to treat 3.1 million people. Monoclonal antibodies, another treatment, are harder to administer but are more effective, which led experts to debate the benefits and drawbacks of an easy-to-use medicine that would offer an additional tool to reduce the strain on hospitals as a potential winter surge looms.
“I voted yes. This was clearly a very difficult decision,” said Michael Green, a professor of pediatrics at the University of Pittsburgh School of Medicine. “Should an alternative oral agent become available that had a better safety profile and equal to or better efficacy profile, the agency might reconsider its authorization.”
When preliminary data on the drug was released in early October, molnupiravir appeared to cut risk of death and hospitalization in half, a finding so persuasive that the trial was halted at its midpoint. After continued follow-up of patients, the drug appeared less impressive, with risk of death and hospitalization reduced by 30 percent — an unexplained erosion that was another factor in some committee members’ hesitancy to endorse the treatment.
“I just want to emphasize that I think it’s a pretty minimal benefit,” said Sally Hunsberger, a statistician at the Biometrics Research Branch of the National Institute of Allergy and Infectious Diseases, who voted no. “I don’t really think we know what groups this is benefiting, if it’s benefiting.”