It is thus expected to become an important tool in the battle to deal with the rapidly spreading Omicron variant.
Data from the Pfizer clinical trial showed that the proposed antiviral regimen of two drugs was 90% effective in terms of preventing hospitalization and death in patients at high risk of developing severe disease. Recent laboratory data suggest that the drug retains its effectiveness against Omicron.
Η FDA 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 stipulates that any treatment regimen will cost 530 dollars. 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.
Green light from the FDA and the antiviral pill MSD
At the same time, use her antiviral pill pharmaceutical industry MSD (s.s. American name Merck) in the treatment of the disease Covid-19 approved on Thursday Food and Drug Administration (FDA) of United States.
Merck's formulation molnupiravir, which he co-developed with Ridgeback Biotherapeutics, reduces hospitalizations and deaths about 30% in a clinical trial performed in people running high risk at the beginning of the disease.
The FDA has approved the use of the oral drug for treatment mild to moderate Covid from adults at risk for serious illness, and from those who do not have access to alternative therapies for Covid-19 or are not clinically suitable for them.