The Covid-19 oral antiviral pill Paxlovid has been approved for use in the European Union for those at risk of severe disease, the bloc’s medical regulators announced Thursday.
The human medicines committee of the European Medicines Agency recommends the pill, developed by pharmaceutical giant Pfizer, be granted conditional marketing authorization, according to an EMA news release.
This makes it the first oral antiviral pill to be recommended in the bloc for treating Covid-19, the EMA said. It follows authorization in the US and the UK.
The EMA’s approval comes after its committee evaluated a study of Covid-19 patients which indicated the treatment “significantly reduced hospitalisations or deaths in patients who have at least one underlying condition putting them at risk of severe Covid-19.”
The EMA continued: “Over the month following treatment, 0.8% (8 out of 1,039) of the patients receiving Paxlovid were hospitalised for longer than 24 hours, compared with 6.3% (66 out of 1,046) of those who received placebo. There were no deaths in the Paxlovid group and 9 deaths in the placebo group.”
Paxlovid combines a new antiviral drug named nirmatrelvir and an older one called ritonavir and is administered as three pills given twice a day for five days.