An advisory panel to the US Food and Drug Administration has voted 13 to 10 to support the emergency use authorization of an antiviral pill from Merck and Ridgeback Biotherapeutics to treat COVID-19, CNN reports.
In October, the companies reported initial data that the drug, molnupiravir, which is taken orally as four capsules twice a day for five days, reduced the risk of hospitalization or death among high-risk COVID-19 patients by 50 percent, as compared to placebo. But a final analysis released last week suggested instead that molnupiravir reduced the risk of hospitalization and death by 30 percent.
NPR notes that panelists discussed potential safety concerns of the treatment, particularly worries that it could lead to mutations beyond the virus and cause birth defects.
"I voted yes because COVID-19 is still an emergency situation. As a frontline clinician in treating patients, both inpatient and outpatient, there is a need for something like this," W. David Hardy from the Charles Drew University School of Medicine and Science, tells CNN. He adds that he does still have "questions about its overall, longer term efficacy."
NPR notes that the FDA generally, but not always, follows the recommendations of its advisory panels and that if it authorizes molnupiravir, it would be the first oral medication for COVID-19.