© Reuters. The U.S. Food and Drug Administration fully approves Pfizer’s new crown drug Paxlovid, becoming the first approved pill for the new crown drug
FX168 Financial News (North America) News Thursday (May 25) Pfizer’s COVID-19 drug Paxlovid received full approval, which is the drug of choice for the treatment of coronavirus.
More than 11 million prescriptions have been filled since the FDA allowed emergency use of Paxlovid in late 2021. The state of emergency is based on earlier research and is temporary until follow-up research.
The U.S. Food and Drug Administration fully approved Paxlovid for adults with COVID-19 who are at high risk of serious illness that could lead to hospitalization or death. This group often includes older adults and people with common medical conditions such as diabetes, asthma and obesity.
The decision allows Pfizer’s drug to remain on the market indefinitely and be marketed similarly to other drugs. Children aged 12 to 17 can still take the drug under a separate emergency authorization.
The U.S. government has stockpiled millions of doses of Paxlovid, which will continue to be available for free to patients, the FDA said in a statement. The U.S. reported more than 14,000 weekly COVID-19 cases last month, even though most U.S. cases are no longer reported to health authorities.
Paxlovid is the fourth COVID-19 drug and the first pill to be fully approved by the Food and Drug Administration. Previously approved treatments were drugs given intravenously or by injection, usually given in a clinic or hospital.
Pfizer initially studied the effects of Paxlovid in the highest-risk COVID-19 patients, including unvaccinated adults with other health problems and no previous evidence of coronavirus infection. In this group of patients, taking Paxlovid shortly after the onset of symptoms reduced the risk of hospitalization or death by 86%, the FDA said.
In a recent study of COVID-19 patients, Paxlovid still significantly reduced the chance of hospitalization or death by more than 85%.
As Paxlovid became more widely available in 2021, doctors and patients reported cases of COVID-19 symptoms days after treatment with the drug Paxlovid. But the U.S. Food and Drug Administration said on Thursday there was “no clear link” between Pfizer’s drug and rebound cases. That conclusion was backed by an independent FDA advisory panel, which voted to recommend full approval of the drug at a meeting earlier this year.
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