Even before the approval of the health authorities, Paxlovid, Pfizer’s anti-Covid pill, was already announced as available in French pharmacies from the end of January. Presented by its manufacturer as the drug capable of changing the situation of the pandemic, this antiviral was authorized on Friday January 21 by the High Authority for Health (HAS) for the early treatment of people at risk of a severe form of Covid-19 (not requiring oxygen therapy). This green light follows an opinion from the National Agency for the Safety of Medicines and Health Products (ANSM). The European Medicines Agency had given a provisional favorable opinion on December 16, 2021.
Paxlovid is the first treatment accessible in town, it can be prescribed by general practitioners, underlines the HAS, which precisely lists the indications. The French State has already ordered 500,000 doses. In fact, on paper, millions of people are potentially affected. Those are “adult patients who are severely immunocompromised or who present with a pathology at very high risk of a serious form – in particular cancers undergoing treatment, polypathologies, trisomy 21 or certain rare diseases, regardless of their age and their vaccination status”. It is also intended “to patients over the age of 65 with risk factors for developing serious forms (diabetes, obesity, chronic renal failure, heart failure, arterial hypertension, respiratory failure, etc.), in particular when these people are not, or not fully vaccinated.
An expected drug, “for patients at risk”
In practice, Paxlovid should be taken for five days (three tablets twice a day), as soon as possible after a positive test and at most within five days of the onset of symptoms.
In the current context of the predominance of the Omicron variant, this oral drug – the first authorized in France – was particularly awaited. “In the absence of effective monoclonal antibodies in this indication, Paxlovid could be the only treatment available to prevent progression to a severe form in infected patients at risk”, point it Scientific Council in its latest opinion, made public on January 20.
Is there a risk of wider use in the population to shorten the duration and intensity of symptoms, especially in the unvaccinated? “Paxlovid should be reserved for patients at risk, it is only in these populations that we have clinical studies and therefore data on the benefit-risk ratio. Pedagogy will be necessary to properly respect the indications », warns Christelle Ratignier-Carbonneil, the director general of the ANSM.
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