EMA approves Pfizer pill

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The European Medicines Agency has given the green light this Thursday to the conditional use commercial license for Pfizer antiviral pills against COVID-19. It is the first oral drug of this type to be authorized in the European Union, after Remdesivir, which is already administered intravenously in hospitals.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the Paxlovid -trade name of the drug-, for the treatment of coronavirus disease in adults who do not require supplemental oxygen and who are at increased risk of complications.

Pfizer’s antiviral contains two active substances, nirmatrelvir (PF-07321332) and ritonavir, in two different tablets. The first acts reducing the ability of SARS-CoV-2 to multiplywhile the second prolongs this action, allowing it to remain longer in our body.

The EMA had already granted a license to Paxlovid for emergency use, so that the national authorities could decide and incorporate it into their strategy against the sixth wave. As reported by the Government, Spain has bought 344,000 doses of Paxlovid from Pfizerwhich will be added to those that correspond to the centralized purchase made by the EU.

Reduces “significantly” the risk of hospitalization and death

For its opinion, the expert committee has evaluated data from a study showing that treatment with Paxlovid reduced “significantly” hospitalizations or deaths in patients with COVID-19 who had at least one underlying risk disease, as explained by the EMA in a statement.

Participants received Paxlovid or placebo within five days of the onset of coronavirus symptoms, without receiving other monoclonal antibody treatments. During the month following treatment, andl 0.8% of patients receiving Paxlovid were hospitalized for more than 24 hours (specifically 8 of 1,039), compared to 6.3% of those who received placebo (66 of 1,046), continues the press release. In addition, there were no deaths in the antiviral group, while there were nine deaths in the placebo group.

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“Most of the patients in the study were infected with the Delta variant. Based on laboratory studies, Paxlovid is also expected to be active against the omicron variant and other variants,” the European regulator’s statement said.

mild side effects

Regarding the safety of Pfizer’s oral antiviral, the EMA has ruled that the side effects are “generally mild”, although it warns of mixing with other drugs. Ritonavir is known to affect the action of many other medications, therefore warnings and advice have been included in the Paxlovid product information.

In addition, Pfizer has made available a drug interaction tool, which can be accessed with a QR code on the package insert and on the outer carton.

For all these reasons, the CHMP has concluded that the “benefits of the drug are greater than its risks” and will send its recommendations to the European Commission, which is responsible for issuing the authorization applicable to all Member States.

Pfizer’s drug is the sixth against Sars-CoV-2 authorized in the European Union, between antivirals and monoclonal antibody therapies (anakinra, regdanvimab, tocilizumab, casirivimab/imdevimab, remdesivir, and sotrovimab). In addition, two other drugs are in the initial phase of evaluation (ixagevimab/cilgavimab) and two more may receive a definitive response soon (molnupiravir and baricitinib).

“We are making good progress in our second line of defense: Promising therapies that can make a real contribution to mitigating the impact of COVID-19,” European Commissioner for Health Stella Kyriakides said in a statement after approving the drug.

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George Holan

George Holan is chief editor at Plainsmen Post and has articles published in many notable publications in the last decade.

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