The Medicines Agency concludes that the benefits outweigh the risks
The European Medicines Agency (EMA in its acronym in English) has given the green light to the conditional commercialization of Paxlovidthe pill against covid-19 of the pharmaceutical company Pfizer. The agency’s human medicines committee has recommended to the European Commission its approval that it be used in the treatment of the disease caused by covid in adults who need supplemental oxygen and who are at higher risk of the disease worsening.
Its about first antiviral drug of oral administration recommended by the European Union for the treatment of coronavirus. It is made up 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, allowing it to remain in the body longer at levels that affect the multiplication of the virus.
According to the EMA analysis, drug benefits are 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 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 to 6.3% (66 of 1,046) of those who received placebo. There were no deaths in the Paxlovid group and 9 in the placebo group. As explained by the agency 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.
As for the security profile of Pfizer’s new antiviral, was favorable, and side effects were generally mild. Still, 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 accessed 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 remind them of the problem.