A new step forward for treatments against Covid-19. The European Medicines Agency (EMA) on Thursday, December 16 approved the emergency use in the European Union of Pfizer’s anti-Covid pill, Paxlovid. And this even if, for the moment, it has not yet received a full marketing authorization. “The drug, which is not yet authorized in the EU, can be used to treat adults with Covid-19 who do not need supplemental oxygen and who are at increased risk of developing a severe form of disease”the EMA said in a statement.
The move comes two days after the pharmaceutical giant announced that its anti-Covid pill reduced hospitalizations and deaths in people at risk by nearly 90%, when taken within five days of onset of symptoms, and for five days. As the continent faces an outbreak of the epidemic, this opinion therefore aims to “support national authorities who can decide on a possible early use of the drug”, she continues. Especially since Paxlovid should remain effective against Omicron, according to Pfizer, which claims to have conducted laboratory tests.
The EMA also launched an expedited treatment review on December 13, 2021 for a possible marketing authorization application.
Antivirals work by reducing the ability of a virus to replicate, thereby slowing down the disease. They are eagerly awaited because they are easy to administer and can be taken at home with a glass of water.
Treatment is not recommended during pregnancy and in people who may become pregnant. Breast-feeding should also be discontinued while taking treatment. Finally, the most common side effects were taste disturbance, diarrhea and nausea.
The EMA had also issued a similar emergency use authorization for a pill from Pfizer’s rival, Merck. But in the case of drug, in France, thehe High Authority of Health had decided to refuse early access to this treatment, doubting its effectiveness.
Earlier today, the European Medicines Agency approved two new treatments for Covid-19: Xevudy, the monoclonal antibody treatment of GlaxoSmithKline, as well as Kineret, marketed by the Swedish company Orphan Biovitrum AB, a medicine immunosuppressant already authorized in the EU for the treatment of various inflammatory conditions.
GSK processing “is intended for the treatment of Covid-19 in adults and adolescents who do not need supplemental oxygen and who are at increased risk for the severity of the disease”, said the EMA in a press release (link in English), while the use of the Kineret has been “extended to the treatment of Covid-19 in adult patients (…) who need supplemental oxygen (…) and who are at risk of developing severe respiratory failure”.