The European Medicines Agency (EMA) has applied for a conditional marketing authorization for Pfizer Paxlovid (PF-07321332 and ritonavir) for the treatment of coronavirus.
According to a statement issued by EMA, it has started evaluating the application for the drug, which is administered orally and is intended for the treatment of mild to moderate COVID 19 disease for adults and adolescents (12 years of age and older weighing at least 40 kg) who are ill and at high risk of serious illness.
The EMA will evaluate the benefits and risks of Paxlovid in a limited time frame and could make its decision in a few weeks, depending on the quality of the data submitted or the need for additional information.
The evaluation is carried out on a shortened schedule due to the fact that the Coreper Committee for Medicinal Products for Human Use (CHMP) has already evaluated a significant part of the drug data in a rolling evaluation, during which it examined data from laboratory and animal studies, such as also data on the quality of the drug.
The panel evaluated data from a study of the effects of Paxlovid in untreated, unvaccinated COVID-19 patients who had symptoms and at least one underlying disease and who were at risk of becoming seriously ill.
At the same time, the EMA safety committee (PRAC) began evaluating the company’s RMP, which describes measures to identify, characterize and minimize the risks of the drug.
The EMA Committee for Pediatric Medicines (PDCO) has issued its recommendation for the company’s Pediatric Research Plan (PIP), which describes how to develop and study the medicinal product for use in children, according to the accelerated timetable for medicines against COVID-19.
If the additional information provided in the application is sufficient to enable the CHMP to conclude that the benefits of Paxlovid outweigh the risks, Coreper in cooperation with the European Commission will expedite the marketing authorization process which will apply to all EU Member States and the European Economic Area.
Paxlovid is an antiviral pill that reduces the ability of the SARS CoV 2 virus to multiply in the body. The active substance PF-07321332 blocks the activity of an enzyme that the virus needs to multiply.
Paxlovid also contains a small dose of ritonavir, which slows down the breakdown of PF-07321332, allowing it to stay in the body longer at levels that affect the virus. The drug is expected to reduce the need for hospitalization in patients with COVID-19.
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