Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) has cleared its COVID-19 antiviral pill, making it the first home-use treatment for the coronavirus, which is expected to become a tool important in the fight against the rapidly spreading omicron variant.
Data from Pfizer’s clinical trial showed that its two-pill antiviral regimen was 90% effective in preventing hospitalizations and deaths in patients at high risk for severe disease. Recent laboratory data suggest that the drug maintains its efficacy against the omicron variant.
The agency licensed the oral drug for treatment in high-risk adult patients and pediatric patients at least 12 years of age with COVID-19 outside of the hospital.
The company said it was ready to start immediate supply in the United States and raised its production forecast to 120 million treatments from 80 million in 2022.
The US government contract for 10 million treatments of Pfizer’s drug is priced at $ 530 per treatment.
The Pfizer pills, which are taken together with the old antiviral drug ritonavir, will be sold under the brand name Paxlovid. The pills should be taken every 12 hours for five days from the onset of symptoms.
Pfizer has said it plans to submit a new drug application to the FDA in 2022 for possible full regulatory approval.
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