US Authorizes Pfizer's COVID-19 Pill Paxlovid
The FDA on Wednesday authorised Pfizer's Paxlovid (nirmatrelvir) for emergency use, making it the first oral antiviral for COVID-19 cleared in the US. The agency said the prescription treatment, which is co-packaged with ritonavir, is indicated for patients aged 12 and older with mild-to-moderate illness who are at high risk for worse disease, including hospitalisation or death, according to a FirstWord Pharma report.
"This authorisation provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge," remarked Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research. Paxlovid should be taken as soon as possible after diagnosis of COVID-19, and within five days of symptom onset, the agency said. It noted that the drug has not been cleared for pre-exposure or post-exposure prevention of COVID-19, nor should it be used for people who have to be hospitalised due to severe or critical illness.