(The Hague) The European regulator on Friday approved the emergency use, before its formal authorization in the European Union, of the anti-COVID-19 pill from Merck, and began a review of the anti-COVID-19 pill. -COVID-19 from Pfizer, as the continent grapples with a new wave of the epidemic.
The two treatments by the US pharmaceutical giants are eagerly awaited, and studies indicate that they reduce the risk of hospitalization and death in patients at risk.
The European Medicines Agency (EMA) said that although Merck’s tablet has not yet been approved, it has “issued recommendations” so that countries in the European Union can individually decide to use it in peak infections.
Member states can therefore now use it “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 press release.
“The EMA has issued this opinion to support national authorities who can decide on a possible early use of the drug before the marketing authorization, for example in emergency situations”, observing “increasing rates of ‘infection and death due to COVID-19 in the EU, “the European regulator said in a statement.
The Merck pill should not be used by pregnant women or women who are not using contraception and could become pregnant, the EMA said.
“These recommendations are given because laboratory studies in animals have shown that high doses of (the Merck pill) may impact the growth and development of the fetus,” he added.
The Amsterdam-based regulator says it hopes to rule on formal authorization of the Merck pill, also known as molnupiravir, by the end of the year.
The EMA separately announced that it has launched a review for emergency authorization of Pfizer’s anti-COVID-19 pill.
“The EMA is reviewing currently available data on the use of Paxlovid, an oral treatment for COVID-19 developed by Pfizer,” the EMA said.
A “continuous” examination of the Pfizer pill, more comprehensive, should begin next week, but the European regulator wanted to be able to support the authorities “as soon as possible”.