Pfizer Turns To FDA For Emergency Approval Of Its COVID-19 Antiviral Pill
NORTH TEXAS (CBSDFW.COM) - A new COVID treatment could be on the way. Pfizer asked the FDA to grant an emergency use authorization for its antiviral pill. It's intended to treat unvaccinated people with mild to moderate COVID-19, who are at high risk for hospitalization or death.
It would be an at-home treatment, with medication taken twice daily for five days. If given within three days of symptoms, it was shown to reduce severe outcomes by 89-percent.
The pill works by keeping the virus from replicating. Pfizer did not provide details of any side-effects, but said reports of adverse events were about the same in the placebo group and the group that actually received the medication. The drug company reported no deaths in the patients who received the drug, compared to 10 who got the placebo.
"The more tools we have to address this, for being able to treat those who are not getting the vaccination for whatever reasons, it helps us reduce this burden of hospitalizations and death," said Dallas County Health and Human Services Director Dr. Philip Huang.
An independent group of medical experts monitoring Pfizer's trial recommended stopping it early, which is standard procedure when the interim results show such a clear benefit.
The FDA hasn't said yet when a panel will meet to discuss the data, but there is a meeting November 30 to discuss a pill treatment created by Merck. Early results in that trial showed the medication could cut hospitalizations and deaths by 50-percent.
