EMA: first oral COVID-19 antiviral drug approved for conditional use

The European Medicines Agency (EMA) has issued a recommendation for a conditional approval for the use of a drug from the Pfizer concern for the treatment of COVID-19. “This is the first orally administered antiviral drug recommended in the EU for the treatment of COVID-19,” reads the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB). The final decision on admission to trading is made by the European Commission.

According to the URPLWMiPB website, “The Committee for Medicinal Products for Human Use (CHMP) EMA recommended that Paxlovid be approved for the treatment of COVID-19 in adults who do not require additional oxygen therapy and are at increased risk of severe disease”.

The preparation is a combination of two antiviral substances – nirmatrelvir and ritonavir, produced by Pfizer. Thanks to them, the multiplication of SARS-CoV-2 is blocked.

The decision on conditional admission to the use of Pfizer’s drug was issued by EMA experts based on the results of studies in which patients with COVID-19 participated. Their conclusions were that treatment with this preparation reduced the number of hospitalizations or deaths of patients with at least one disease that exposed them to a severe course of infection.

«Most of the patients in the study were infected with the Delta variant. Based on laboratory tests, Paxlovid is also expected to be active against the Omikron variant and other variants » – informs the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

As we read on the URPLWMiPB website, “Paxlovid’s safety profile was favorable and the side effects were generally mild. However, ritonavir is known to affect the action of many other drugs, and warnings and advice have been included in Paxlovid’s product information. In addition, the company has made available on its website a tool that helps to obtain information about the product’s interactions with other drugs, which can be accessed using the QR code included in the information printed and on the outer packaging ».

URPLWMiPB announces that an assessment report will be published shortly, including details of the drug’s assessment by EMA and a full risk management plan. “The clinical trial data submitted by the company in the marketing authorization application will be published on the Agency’s clinical data website in due course”.

The Authority also recalls that the Conditional Marketing Authorization (CMA) “ensures that the approved medicine meets stringent EU standards of efficacy, safety and quality”. Once granted, companies must provide further data within predetermined deadlines to confirm that the benefits still outweigh the risks. More information is available on the website Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

It should not be forgotten that this drug is by no means a substitute for vaccination against COVID-19.

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