FDA: Approves Pflovid Paxlovid Antiviral Pill for Home Use
Who was the FDA approved for?
Pharmaceutical company Pfizer Inc announced yesterday that the US Food and Drug Administration (FDA) has approved its antiviral pill for Covid-19, making it the first treatment for the new coronavirus that can be taken at home and is expected to become an important tool in the fight against the rapidly spreading omicron mutation.
Data from the Pfizer clinical trial showed that the proposed two-drug antiviral regimen was 90% effective in preventing hospitalization and death in patients at high risk of developing severe disease. Recent laboratory data suggest that the drug retains its effectiveness against the micron.
The FDA has approved the oral formulation for the treatment of high-risk adult patients and pediatric patients at least 12 years of age outside the hospital.
The company assured that it is ready to immediately start deliveries to the US and increase production forecast to 120 million therapies, from 80 million by 2022. The US government contract states that each therapies will cost $ 530.
The US has ordered 10 million regimens to date. Pfizer pills, to be taken in combination with the older antiviral drug ritonavir, will be sold under the brand name Paxlovid. The pills should be taken every 12 hours for five days, shortly after the onset of symptoms Covid-19.
Pfizer has said it intends to submit a new application to the FDA in 2022 seeking full approval from regulators for its drug.