FDA authorizes first COVID-19 treatment pill
It's about time!
Emergency use authorization was granted Wednesday for Pfizer's Paxlovid – nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use – for the treatment of mild-to-moderate coronavirus disease in adults and children 12 years of age or older weighing at least 40 kilograms or about 88 pounds.
It applies only to those who meet those qualifications, have tested positive for SARS-CoV-2 testing and "who are at high risk for progression to severe COVID-19, including hospitalization or death," the FDA said.
Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.
In a randomized, double-blind, placebo-controlled clinical trial, Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88% compared to placebo among patients treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment.
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Link: FDA authorizes first COVID-19 treatment pill
Posted: 12/22/2021 at 3:13PM