Filenews 31 January 2022
The Committee for Medicinal Products for Human Use of the EMA (CHMP) recommends the issue of a conditional marketing authorisation for the oral antiviral drug Paxlovid (PF-07321332/ ritonavir) for the treatment of COVID-19. The applicant is Pfizer Europe MA EEIG.
The Commission recommended the authorisation of Paxlovid for the treatment of COVID-19 in adults who do not need supplemental oxygen and who are at increased risk of progression to severe disease.
Paxlovid is the first oral antiviral drug recommended in the EU to treat COVID-19. 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 multiply in the body while ritonavir prolongs the action of PF-07321332 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 that included patients with COVID-19, which showed that treatment with Paxlovid significantly reduced hospitalizations or deaths in patients with at least one underlying disease, which put them at risk of severe illness with COVID-19. The analysis was carried out in patients who received Paxlovid or placebo (a dummy treatment) within 5 days of the onset of symptoms from COVID-19 and who did not receive, or expected to receive, antibody therapy. During the month following treatment, the hospitalization or death rate (2) was 0.8% (8 out of 1,039) of patients taking 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 group that received Paxlovid and 12 (1) deaths were recorded in the group that received the 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.
Paxlovid's safety profile was favourable, and side effects were generally mild. However, it is known that ritonavir affects the action of many other drugs, and relevant warnings and recommendations have been included in the information about the drug 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 in the outer packaging box. A letter will also be sent to the relevant organisations of health professionals to further remind them of this issue. The CHMP concluded that the benefits of the medicine are greater than the risks for its authorised use and will now send its opinion on this 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 public and details of the conditions of approval of the medicine.
The evaluation report with details on the EMA's assessment of Paxlovid and the full risk management plan will be published shortly. Clinical trial data submitted by the company in the application for marketing authorisation will be published on the Agency's clinical trials website in due course.
More information will also be available in a review of the medicine in plain language, 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 across the EU.
The conditional marketing authorisation (CMA) is used as a fast-paced authorisation procedure to accelerate the authorisation of medicines during public health emergencies in the EU. CMAs allow the licensing of drugs that meet an unmet medical need on the basis of less comprehensive data than is usually required. This is the case if the benefit of the immediate availability of a drug to patients outweighs the risks they exist given the lack of timely availability of all data.
The CMA guarantees that the authorised medicine meets the strict EU standards on efficacy, safety and quality and that it is produced in approved, certified facilities in accordance with the high pharmaceutical standards for large-scale production.
When the CMA is granted, companies must provide further information within predetermined deadlines to confirm that the benefits continue to outweigh the risks.
For Paxlovid, the company marketing the drug will provide further data to enhance certainty about the pharmaceutical quality of the product.
Paxlovid rating
During the Paxlovid evaluation, the CHMP had received the support of the EMA Safety Commission, PRAC, which assessed Paxlovid's risk management plan, as well as the COVID-19 EMA task force (COVID-ETF), a team that brings together experts from across the network of European regulators to facilitate rapid and coordinated regulatory action on covid-19 medicines and vaccines.
Paxlovid was evaluated as part of "OPEN", an initiative launched in December 2020 aimed at strengthening international cooperation in the evaluation, at EU level, of vaccines and treatments against COVID-19. More information is available on the EMA website.
1. On January 28, 2022, this proposal was amended to refer to hospitalization or death (and not just hospitalization) to fully describe the results.
2. On 28 January 2022, this number was corrected to reflect the data analysed: there were 12 deaths (and not 9) in the placebo group.
