The European Medicines Agency (EMA) said on Thursday it had approved emergency use in the European Union of Pfizer’s anti-Covid pill, which has yet to receive full marketing authorization. the market.
The European Medicines Agency (EMA) said on Thursday it had approved emergency use in the European Union of Pfizer’s anti-Covid pill, which has yet to receive full marketing authorization. Marlet. “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 the disease, “the EMA said in a statement.
Effective against Omicron
“The EMA has issued this opinion to support national authorities who can decide on a possible early use of the drug” as the continent faces an outbreak of the epidemic. The pharmaceutical giant announced earlier this week that its anti-Covid pill reduced hospitalizations and deaths in people at risk by almost 90% when taken in the first days after symptoms appeared.
The latter, named Paxlovid, should remain effective against Omicron according to laboratory tests, Pfizer also announced. The EMA recommendation is based on interim results from the main study in outpatients and unvaccinated patients with symptomatic disease who were at risk of developing a severe form of the disease.
Reduced risk of hospitalization
These results indicate that Paxlovid “reduced the risk of hospitalization and death when treatment was given within 5 days of onset of symptoms”, and treatment should be extended over five days. 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. The most common side effects were taste disturbance, diarrhea and nausea. The EMA also launched an expedited treatment review on December 13, 2021 for a possible marketing authorization application. The European Medicines Agency had issued a similar emergency use authorization for a pill from Pfizer’s rival, Merck.