Filenews 10 January 2022
The EMA is receiving a conditional marketing authorisation application for Paxlovid (PF-07321332 and ritonavir) for the treatment of patients with COVID-19 disease.
According to an announcement by the Ministry of Health, the EMA has begun evaluating the application for a conditional marketing authorisation for the oral antiviral drug Paxlovid (PF-07321332 and ritonavir). The applicant is Pfizer Europe MA EEIG.
The application concerns the treatment of mild to moderate COVID 19 disease in adult and adolescent patients (aged 12 years and older with a weight of at least 40 kg) who are at high risk of developing to severe COVID 19 disease.
The EMA will assess the benefits and risks of Paxlovid in a shortened timeframe and may issue an opinion within weeks, depending on whether the data submitted is strong enough and whether further information is needed to support the assessment.
Shortened timing is possible as the EMA has already evaluated a significant part of the data on the drug during a rolling review during which it evaluated data from laboratory and animal studies, as well as data on the quality of the drug. In addition, the CHMP evaluated data from a study on Paxlovid's actions in non-hospitalized, unvaccinated COVID-19 patients who have had symptomatic disease and at least one underlying condition and who are at increased risk of developing their disease condition into severe.
At the same time, the EMA's Safety Committee (PRAC) began evaluating the company's proposed Risk Management Plan (RMP), which outlines measures to identify, characterize and minimize the risks of the drug. In addition, the EMA Committee on Medicines for Children (PDCO) has issued its recommendation for the company's paediatric investigation plan (PIP), which describes how the drug is developed and studied for use in children, in line with accelerated timelines for drugs against COVID-19.
Since the additional information submitted in the application for a marketing authorisation is sufficient for the CHMP to conclude that Paxlovid's benefits are more than its risks in the treatment of COVID-19, the EMA will work closely with the European Commission to speed up the marketing authorisation approval process which will be valid in all EU and EEA Member States.
The EMA will contact further in the opinion of the CHMP.
How the drug is expected to work
Paxlovid is an oral antiviral drug that reduces the ability of the SARS CoV 2 virus (the virus that causes COVID-19) to multiply in the body. The active substance PF-07321332 prevents the activity of an enzyme that the virus needs to multiply. Paxlovid also contains a low dose of ritonavir (a protease inhibitor), which slows down the breakdown of PF-07321332, allowing it to remain longer in the body at levels that affect the virus. The drug is expected to reduce the need for hospitalization in patients with COVID-19.
