European Union approves first COVID-19 pill

The European Medicines Agency (EMA) has announced that it has issued the conditional marketing authorization (CMA) for Pfizer’s oral coronavirus treatment, Paxlovid.

Amid the ongoing spread of the virus’s Omicron strain in Europe, EMA said that the first coronavirus treatment pill 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 said, is used to speed up the authorization process of medicines “during public health emergencies.”

With the European regulator’s approval, 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.