Europe approves use of Pfizer’s covid-19 pill

The Medicines Agency concludes that the benefits outweigh the risks

The European Medicines Agency (EMA in its acronym in English) gave the green light for the conditional commercialization of Paxlovid, the pill teen Covid-19 from the pharmaceutical company Pfizer. The Agency’s Committee for Human Medicine has recommended to the European Commission that it be used in the treatment of covid’s disease in adults who require supplemental oxygen and who are at greater risk of exacerbating the disease.

It’s about first antiviral drug of oral administration recommended by the European Union for the treatment of coronavirus. It consists of two active substances, PF-07321332 and ritonavir, in two different tablets. The first acts by reducing the ability of the virus that causes covid-19 to multiply in the body, while ritonavir prolongs its action so that it can stay longer in the body at levels that affect the multiplication of the virus.

According to the EMA analysis, drug benefits is greater than their risks. The studies reviewed show that Paxlovid treatment significantly reduced hospitalizations or deaths in patients who had at least one underlying disease that increased the risk of severe covid. The evaluation was performed in patients who received Paxlovid or placebo within 5 days of symptom onset and those who did not receive antibody treatment and were not expected to receive antibody treatment.

Positive results

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During the month following treatment, only 0.8% (8 of 1,039) of patients who received Paxlovid were hospitalized for more than 24 hours compared with 6.3% (66 of 1,046) of those who received received placebo. There were no deaths in the Paxlovid group and 9 in the placebo group. As the agency explained in a statement, most of the patients in the study were infected with the Delta variant, although according to laboratory tests, Paxlovid is also expected to be active against the omicron and other variants.

The security profile of Pfizer’s new antiviral drug, was beneficial, and side effects were generally mild. However, because ritonavir affects the action of many other medicines, warnings and advice have been included in the product information. In addition, the company has provided a drug interaction tool on its website, which can be obtained via a QR code included in the product information and on the outer carton, and a letter will be sent to relevant healthcare professionals to help them address the issue. to remember. .

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