The European Medicines Regulator said Monday that it has begun evaluating Pfizer’s application for its pills to treat the effects of COVID-19.
The announcement comes at a time when countries in most of the 27-country bloc are reporting skyrocketing infections as the highly transmitted omicron variant spreads across the continent.
The European Medicines Agency said in a statement that it could decide within weeks whether or not Pfizer’s application for conditional marketing authorization for Paxlovid should be approved, “depending on whether the data provided is reliable enough and whether additional information is required to support evaluation. “
Late last month, U.S. health regulators approved pills that patients can take at home to stave off the worst effects of the virus. At the time, Pfizer said it had 180,000 treatments available worldwide, of which approximately 60,000–70,000 were allocated to the United States. The company said that 250,000 courses will be available in the US by the end of January.
Pfizer’s EMA filing concerns the use of pills to treat mild to moderate COVID-19 in patients aged 12 and over who are at risk of developing severe symptoms.
Last month, the EMA issued guidelines for the use of the drug for EU countries that wanted to start using it before receiving official approval. The agency said it based its recommendations on a study of non-hospitalized, unvaccinated patients who had COVID-19 and at least one underlying medical condition that put them at risk of developing severe symptoms of COVID-19.
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“These data showed that Paklovid reduced the risk of hospitalization and death when treatment was started within five days of the onset of symptoms,” the agency said.