First oral Covid treatment approved in EU
The European Medicines Agency (EMA) has given its conditional approval to Pfizer’s Covid-19 pill, amid the continued spread of the virus’ Omicron variant in the region.
Announcing the conditional marketing authorization (CMA) of the treatment, the EMA said that Paxlovid has been recommended “for treating Covid-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.”
The CMA mechanism, the EMA notes, is used to speed up the authorization process of medicines “during public health emergencies.”
The regulator added that Paxlovid has become “the first antiviral medicine to be given by mouth that is recommended in the EU for treating Covid-19.”
The approval of Paxlovid follows the authorization in December of antibody treatment Xevudy, produced by GlaxoSmithKline and Vir Biotechnology, as well as Kineret by Swedish company Sobi, which was originally an arthritis drug but is able to “reduce” Covid-related inflammation.
Paxlovid’s competitor, Merck’s Lagevrio (molnupiravir), remains under consideration by the EMA, as its effectiveness has proved to be lower than expected.
Both Paxlovid and molnupiravir received approval from the US Food and Drug Administration in December last year.