The European Medicines Agency (EMA) announced on Friday the approval in the European Union of Merck’s anticovid pill for emergency use, although it has not yet received full marketing authorization.
On the other hand, it launched the evaluation of Pfizer’s anticovid pill, in a context of a new wave of infections in Europe.
These treatments from two American pharmaceutical giants are highly anticipated because studies indicate that they reduce the risk of hospitalization and death in at-risk patients.
The EMA said that although the Merck It had not yet been approved and had “issued recommendations” so that the different countries of the European Union could decide on its use in the event of a spike in infections.
Member states will be able to use it for the time being “to treat adults with Covid-19 they do not require supplemental oxygen and are at increased risk of developing a severe form “of the disease, the EMA said in a statement.
The EMA has issued this opinion to support national authorities who can decide on a possible early use of the drug before marketing authorization, for example in emergency situations, “said the regulator.
The Merck pill should not be used by pregnant women or by women who do not use contraception and may become pregnant, according to the EMA.
The recommendations are explained because high doses of the Pill Merck “They can have an impact on the growth and development of the fetus,” according to the studies, the agency said.
The Amsterdam-based regulatory body says it hopes to decide on formal approval of the pill Merck, also known as molnupiravir, by the end of the year.
In parallel, the EMA announced that it began to study the emergency authorization of the anticovid pill from Pfizer.
“The EMA is reviewing the currently available data on the use of Paxlovid, a oral treatment for Covid-19 developed by Pfizer“, said.
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