The EMA Commission for Human Use (CHMP) said in a statement that it recommended a conditional marketing authorization for Paxlovid oral antiviral drug (PF-07321332 / ritonavir) for the treatment of the disease. COVID-19. The applicant is Pfizer Europe MA EEIG.
The Commission has recommended the licensing of Paxlovid for the treatment of the disease COVID-19 in adults who do not need supplemental oxygen and who are at increased risk of developing severe disease.
Paxlovid is the first oral antiviral drug in the EU to treat the disease COVID-19. It contains two active ingredients, PF-07321332 and ritonavir, in two different tablets. PF-07321332 works by reducing the capacity of the SARS-CoV-2 virus (the virus that causes the disease) COVID-19) while the ritonavir prolongs the action of PF-07321332 by allowing it to remain longer in the body at levels that affect the multiplication of the virus.
To reach its conclusion, the CHMP evaluated data from a study involving patients with the disease COVID-19, which showed that treatment with Paxlovid significantly reduced hospitalization or death in patients with at least one underlying disease, which put them at risk for severe disease COVID-19. The analysis was performed in patients receiving Paxlovid or placebo (placebo) within 5 days of the onset of symptoms. COVID-19 and who did not receive, nor were they expected to receive, antibody therapy. During the month following treatment, 0,8% (8 of 1.039) of patients receiving Paxlovid were hospitalized for more than 24 hours, compared with 6,3% (66 out of 1). 046) of those who received placebo. There were no deaths in the Paxlovid group and 9 deaths were recorded in the placebo group.
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 favorable and the side effects were generally mild. However, ritonavir is known to affect the action of many other medicines, and warnings and recommendations have been included in the information about 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 organizations of health professionals to further remind them of this issue. The CHMP has concluded that the benefits of the drug outweigh the risks to its authorized use and will now send its opinion to the European Commission for a speedy decision valid in all EU Member States.
Where to find more information
Paxlovid product information contains information for healthcare professionals, a package leaflet for the general public, and details of the drug approval terms.
The evaluation report detailing the EMA evaluation for Paxlovid and the full risk management plan will be published shortly. The clinical trial data submitted by the company in the marketing authorization application will be published on the Agency's clinical trial website in due course.
More information will also be available in a plain language review of the drug, including a description of the benefits and risks of the drug and why the EMA recommended its EU licensing.
Conditional marketing authorization
The European Commission will now speed up the process of making a conditional marketing authorization for Paxlovid, allowing the drug to be marketed throughout the EU.
Conditional Marketing Authorization (CMA) is used as a rapid licensing process to expedite the authorization of medicines during public health emergencies in the EU. usually required. This happens if the benefit of the immediate availability of a drug to patients outweighs the risks given the untimely availability of all data.
The CMA guarantees that the approved medicinal product meets the strict EU standards of efficacy, safety and quality and that it is produced in approved, certified facilities in accordance with the highest pharmaceutical standards for large-scale production.
Once the CMA is granted, companies must provide further information within a pre-determined timeframe to confirm that the benefits continue to outweigh the risks.
For Paxlovid the company marketing the drug will provide further data to enhance the assurance of the medicinal quality of the product.
Evaluation of Paxlovid
In evaluating Paxlovid, the CHMP had the support of the EMA Safety Committee, PRAC, which evaluated the Paxlovid risk management plan, as well as the team COVID-19 EMA task force (COVID-ETF), a team bringing together experts from across the network of European regulators to facilitate rapid and coordinated regulatory action on drugs and vaccines against the disease COVID-19.
Paxlovid was evaluated as part of OPEN, an initiative launched in December 2020 to strengthen international cooperation in the evaluation, at EU level, of vaccines and treatments against the disease COVID-19. More information is available on the EMA website.