The Committee for Medicinal Products for Human Use of the EMA (CHMP) recommends the conditional marketing authorisation for the oral antiviral drug Paxlovid (PF-07321332/ritonavir) for the treatment of COVID-19 disease. The applicant is Pfizer Europe MA EEIG.
The Committee recommended the authorisation of Paxlovid for the treatment of COVID-19 disease in adults who do not require supplemental oxygen and who are at increased risk of progression to severe disease. Paxlovid is the first oral antiviral medicine recommended in the EU for the treatment of COVID-19 disease. It contains two active substances, PF-07321332 and ritonavir, in two different tablets. PF-07321332 acts by reducing the ability of the SARS-CoV-2 virus (the virus that causes COVID-19) to replicate in the body, while ritonavir prolongs the action of PF-07321332 by allowing it to stay longer in the body at levels that affect the replication of the virus.
To reach its conclusion, the CHMP evaluated data from a study that included patients with COVID-19 disease, which showed that treatment with Paxlovid significantly reduced hospitalizations or deaths in patients with at least one underlying disease that put them at risk of severe disease with COVID-19 disease. The analysis was performed in patients who received Paxlovid or placebo (placebo) within 5 days of the onset of symptoms from COVID-19 disease and who were not receiving, nor expected to receive, antibody therapy. During the month following treatment, 0.8% (8 of 1,039) of patients receiving Paxlovid were hospitalized for longer than 24 hours, compared with 6.3% (66 of 1,046) of those receiving placebo. There were no deaths in the group receiving Paxlovid and 9 deaths were recorded in the group receiving placebo.
The majority of 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 safety profile of Paxlovid was favourable and adverse events were generally mild. However, ritonavir is known to affect the action of several other drugs, and relevant warnings and recommendations have been included in the information for Paxlovid. In addition, the company provides a drug interaction tool on its website, which is accessible via a QR code which is included in the product information and on the outer packaging box. A letter will also be sent to the relevant healthcare professional organisations to further remind them of this issue. The CHMP concluded that the benefits of the medicinal product outweigh the risks for its authorised use and will now send its opinion to the European Commission for a rapid decision with effect in all EU Member States.
Where to find more information
The product information for Paxlovid contains information for healthcare professionals, a package leaflet for the general public and details of the conditions of authorisation of the medicine.
The assessment report detailing the EMA's assessment of Paxlovid and the full risk management plan will be published shortly. The clinical trial data submitted by the company in the marketing authorisation application will be published on the Agency's clinical trial website in due course.
Further information will also be available in a plain language review of the medicine, including a description of the benefits and risks of the medicine and why the EMA recommended its authorisation in the EU.
Conditional marketing authorisation
The European Commission will now speed up the decision-making process on the conditional marketing authorisation for Paxlovid, allowing the medicine to be marketed throughout the EU. Conditional Marketing Authorisation (CMA) is used as a fast-track authorisation procedure to speed up the approval of medicines during public health emergencies in the EU. CMAs allow the authorisation of medicines that meet an unmet medical need on the basis of less comprehensive data than is normally required. This occurs if the benefit of the immediate availability of a medicine to patients outweighs the risks involved given the untimely availability of all data.
A CMA guarantees that the authorised medicine meets strict EU standards for efficacy, safety and quality and that it is produced in approved, certified facilities in accordance with high pharmaceutical standards for large-scale production.
Once a CMA is granted, companies must provide further data within p Further information is available on the EMA website.
(AF)
Contents of this article including associated images are owned by PIO
Views & opinions expressed are those of the author and/or PIO
Source
