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On December 22, the American health authorities urgently authorized the anti-Covid Paxlovid pill from the Pfizer laboratory, for people infected with the virus at risk of serious forms.
The “first treatment for Covid-19 in pill form to be taken by mouth” which is “a new tool”In the fight against the pandemic. This is how Patrizia Cavazzoni, director of the Center for the Evaluation and Research of Medicines Food and Drug Administration (FDA; American equivalent of ANSM), presented the new drug from the Pfizer laboratory authorized for emergency in the United States, in a press release published on December 22.
Paxlovid: for patients at risk of severe forms
Baptized Paxlovid, it is an antiviral indicated for the treatment of patients over 12 years of age who test positive for Covid-19 and at risk of severe forms of infection (hospitalization or death). Composed of nirmatrelvir, which prevents the replication of the virus, and ritonavir, which potentiates this effect, this drug is “available by prescription only” and “should be initiated as soon as possible after the diagnosis of Covid-19 and within five days of the onset of symptoms”.
The FDA insists: Paxlovid is not a substitute for vaccination, but it reinforces the therapeutic arsenal in the fight against Covid-19 at a time when new variants are appearing. And an emergency authorization is not a final approval. But for now, US health authorities consider the benefit-risk balance of treatment favorable. “There are no adequate, approved and available alternatives to Paxlovid for the treatment of Covid-19”, They say.
Paxlovid: deaths and hospitalizations reduced by 88%
For this emergency authorization, the FDA relied on the results of a randomized, double-blind, placebo-controlled clinical trial conducted on more than 2000 patients. The participants, over the age of 18 and unvaccinated, were positive for Covid-19 and had risk factors for progression to a serious form (chronic diseases, etc.). “Paxlovid significantly reduced the proportion of people hospitalized or deceased by 88% compared to placebo among patients treated within five days of onset of symptoms who have not received treatment with monoclonal antibodies against Covid-19”, Emphasizes the FDA.
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Paxlovid: its safety and efficacy “continue to be evaluated”
The safety and effectiveness of Paxlovid, which is taken two tablets per day for five days, “continue to be evaluated”. Several side effects have already been identified, including diarrhea, altered taste perception (dysgeusia), increased blood pressure and muscle pain.
On December 16, the European Medicines Agency (EMA) had already approved the use of Paxlovid in an emergency “to treat adults who do not need supplemental oxygen and who are at increased risk of progressing to a severe form”.
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