The Food and Drug Administration (FDA) scheduled a meeting for late next month for its advisory panel to discuss Merck’s antiviral pill designed to treat mild-to-moderate COVID-19.
The medication could be a game changer in the U.S.’s fight against the virus.
The federal agency announced on Thursday that the advisory committee will meet on Nov. 30 to review data on molnupiravir. If approved, the oral pill would be given to adults who recently tested positive for COVID-19 and are at high risk of severe illness, hospitalization and death.
Merck applied for an emergency use authorization for the drug, developed with Ridgeback Biotherapeutics, earlier this week after trials showed it reduced the risk of hospitalization by 50 percent.
In the results that top infectious diseases expert Anthony Fauci called “impressive,” no deaths were reported among patients who received molnupiravir while eight people died from the placebo group.
“We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use,” Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
The five-day oral treatment could be key in getting the U.S. closer to the light at the end of the tunnel in the pandemic, experts have said, along with authorization for the vaccine to be given to younger children.
The U.S. government has agreed to purchase 1.7 million doses of Merck’s treatment if the FDA grants it emergency use authorization, although former FDA Commissioner Scott Gottlieb said the amount is “not enough.”
But White House health officials, including Fauci, have emphasized that the COVID-19 vaccines would still be needed even with Merck’s antiviral pill to avoid infection in the first place.
The FDA advisory panel this week is considering whether to recommend booster shots for Moderna and Johnson & Johnson recipients.
The committee voted unanimously on Thursday to recommend a third dose of Moderna for those aged 65 and older and adults at high risk of severe COVID-19 due to their medical conditions, jobs or living situations.