EU health authority weighs authorization of Pfizer's Covid-19 pill
Amsterdam, 10 January 2022 (dpa/MIA) - The European Medicines Agency (EMA) is considering whether to authorize a Covid-19 antiviral pill made by pharmaceutical company Pfizer, which says the treatment reduces both hospitalizations and deaths.
Pfizer has applied for the approval of Paxlovid to prevent severe disease in patients aged 12 and up with Covid-19.
EMA scientists expect to make a recommendation within "a few weeks" after evaluating the drug's benefits and risks, according to the agency. They have been reviewing the data for some time.
Pfizer says patients taking the drug would take three tablets twice a day for five days. The active ingredient, nirmatrelvir, is designed to inhibit a Sars CoV-2 protein to prevent the virus from replicating.
The manufacturer has listed possible side effects as including impaired sense of taste, diarrhoea, high blood pressure and muscle pain.
The agency has already given European member states the green light to authorize the drug in emergencies, on a national basis.
Germany, for example, is already preparing to take this step and has ordered 1 million packs of the drug, according to Health Minister Karl Lauterbach.
"The drug is particularly suitable for the treatment of unvaccinated risk patients," the minister had said.
The treatment was cleared for use by regulators in the United States last month and the country's hospitals are now using it as they confront a surge of Omicron cases.