EMA should issue an opinion for the marketing of Pfizer's drug against covid-19 "within weeks"

The European Medicines Agency (EMA) announced this Monday that it is evaluating Pfizer’s application for the marketing of the drug Paxlovid, intended for mild and moderate cases of covid-19.

“EMA has started to evaluate a conditional marketing authorization application for the oral antiviral drug Paxlovid” submitted by Pfizer Europe MA EEIG, the European regulator said in a statement.

According to the EMA, the evaluation will focus on the risks and benefits of this drug for mild or moderate cases of covid-19 in adults and adolescents from 12 years of age and who present a significant risk of worsening the disease.

Opinion may be released “within weeks”

“The EMA will assess the benefits and risks of Paxlovid within a short timeframe and may issue an opinion within weeks” if the data presented is sufficiently robust, the regulator said.

According to the statement, this deadline is only possible because the Committee for Human Medicines (CHMP) has already carried out the ongoing review of Paxlovid, a regulatory instrument to accelerate the evaluation of a new drug in public health emergencies, which included data laboratory, animal and clinical studies.

The CHMP also evaluated the interim results of the pivotal study on the use of Paxlovid in non-hospitalized and unvaccinated patients who had symptomatic disease and at least one underlying disease that put them at risk for severe Covid-19.

If the additional data presented is sufficient for the CHMP to conclude that the benefits of Paxlovid outweigh the risks, the EMA will work with the European Commission to “accelerate the decision to grant a conditional marketing authorization in all Member States”, assured the regulator.

Paxlovid is an oral antiviral medicine that reduces the ability of SARS-CoV-2 to multiply in the body.

The regulator hopes that Paxlovid will reduce the need for hospitalization in patients with covid-19.

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