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The European medicines regulator said on Monday it had begun evaluating applications Pfizer Pills used to treat the effects of COVID-19.
The announcement comes as most of the 27-nation bloc report a spike in infections as the highly-spreading variant of the omicron sweeps across the continent.
In a statement, the European Medicines Agency said it could decide within weeks whether to approve Pfizer’s conditional marketing authorization application for Paxlovid, “depending on whether the data submitted are sufficiently reliable and whether further steps are needed.” information to support the assessment.”
Late last month, U.S. health regulators approved a pill that patients can take at home to ward off the worst effects of the virus. At the time, Pfizer said it had 180,000 courses of treatment worldwide, with about 60,000 to 70,000 allocated to the United States. The company said it expects to have 250,000 treatments in the US by the end of January.
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Pfizer’s application to the EMA includes the use of the pill to treat mild to moderate COVID 19 in patients 12 years and older who are at risk for severe symptoms.
The EMA last month issued recommendations for the use of the drug to EU countries that want to start using the drug before official authorisation. The agency said its recommendations were based on a study of nonhospitalized, unvaccinated patients with COVID-19 who had at least one underlying medical condition that put them at risk of developing severe COVID-19 symptoms.
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“These data suggest that Paxlovid reduced the risk of hospitalization and death when treatment was started within five days of onset of symptoms,” the agency said.
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