Application for a conditional marketing authorization for the drug Paxlovid (PF-07321332 and ritonavir) of Pfizer for its treatment coronavirus received the European Medicines Agency (EMA).
According to a statement issued by EMA, it has started the evaluation of the application for the drug, which is administered orally and is intended for the treatment of mild to moderate disease from COVID-19 for adults and adolescents (aged 12 years and over weighing at least 40 kg) who are ill and at high risk of serious disease.
According to APE, citing this announcement, the EMA will assess the benefits and risks of Paxlovid in a limited time frame and could issue its decision in a few weeks, depending on the quality of the data submitted or the need to submit 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 Evaluate a significant portion of drug data in a rolling evaluation, in which it examines data from laboratory and animal studies, as well as data on drug quality.
This committee evaluated data from a study on the action of Paxlovid in non-hospitalized, unvaccinated patients with COVID-19 who had symptoms and at least one underlying disease and who are at risk of becoming seriously ill.
At the same time, the EMA Security Committee (WASHstarted the evaluation of the risk management plan (RMP) of the company which describes measures for the identification, characterization and minimization of the risks of the medicinal product.
The EMA Committee on Pediatric Medicines (PDCO) issued its recommendation for the company’s pediatric research plan (PIP), which describes how the drug was developed and studied for use in children, according to the accelerated drug schedule versus COVID-19.
If the additional information provided in the application is considered sufficient for the CHMP to conclude that Paxlovid’s benefits 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.
How the antiviral pill works
Paxlovid is an antiviral pill that reduces the ability of the SARS CoV 2 virus to multiply in the body. The active substance is PF-07321332 inhibits the activity of an enzyme that the virus needs to multiply, is noted in the relevant publication of ΑΠΕ ΜΠΕ.
Paxlovid also contains a small dose of ritonavir, 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.
It has recently become known how the United States has doubled its orders to Pfizer, as well as that the preparation received the “green light” of the British authorities, among other countries.
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