The Hague: EU drug watchdog backed Friday Merck‘s anti-covid pill for emergency use prior to its formal authorization and began review pfizerAntiviral treatment of the disease is increasing across Europe.
two bullets by america pharma giant They represent a potentially important step in the fight against the coronavirus as studies show they reduce the risk of hospitalization and death in high-risk patients.
NS European Medicines Agency ,EMA) said that while the Merck pill had not yet been approved, it “issued advice” so that individual countries in the 27-nation EU can decide whether to use it in case of an increase in infections.
The EMA said in a statement, “The drug, which is not currently authorized in the European Union, can be used to treat adults with COVID-19 who do not require supplemental oxygen and who have severe COVID-19.” at risk of developing
“The EMA issued this advisory to support national authorities that may decide on potential early use of the drug prior to marketing authorization, for example in emergency use settings, due to rising infection rates and the risk of COVID-19 in the European Union. In light of the deaths caused.”
The Merck pill should not be used by pregnant women or women who are not using contraception and may become pregnant, the EMA said.
“These recommendations are made because laboratory studies in animals have shown that high doses of[the Merck pill]may affect fetal growth and development,” it added.
The Amsterdam-based watchdog says it expects to decide on formal approval for the Merck pill, also known as mollupiravir, by the end of the year.
Separately, the EMA said it has begun reviewing Pfizer’s pill so that it can provide similar advice.
“Reviewing currently available data on the use of EMA paxlovid, an oral treatment for COVID-19 developed by Pfizer,” the EMA said.
A full “rolling review” for formal approval is expected to begin next week, but the EMA said it wants to be able to help national authorities “in the shortest possible time frame”.
two bullets by america pharma giant They represent a potentially important step in the fight against the coronavirus as studies show they reduce the risk of hospitalization and death in high-risk patients.
NS European Medicines Agency ,EMA) said that while the Merck pill had not yet been approved, it “issued advice” so that individual countries in the 27-nation EU can decide whether to use it in case of an increase in infections.
The EMA said in a statement, “The drug, which is not currently authorized in the European Union, can be used to treat adults with COVID-19 who do not require supplemental oxygen and who have severe COVID-19.” at risk of developing
“The EMA issued this advisory to support national authorities that may decide on potential early use of the drug prior to marketing authorization, for example in emergency use settings, due to rising infection rates and the risk of COVID-19 in the European Union. In light of the deaths caused.”
The Merck pill should not be used by pregnant women or women who are not using contraception and may become pregnant, the EMA said.
“These recommendations are made because laboratory studies in animals have shown that high doses of[the Merck pill]may affect fetal growth and development,” it added.
The Amsterdam-based watchdog says it expects to decide on formal approval for the Merck pill, also known as mollupiravir, by the end of the year.
Separately, the EMA said it has begun reviewing Pfizer’s pill so that it can provide similar advice.
“Reviewing currently available data on the use of EMA paxlovid, an oral treatment for COVID-19 developed by Pfizer,” the EMA said.
A full “rolling review” for formal approval is expected to begin next week, but the EMA said it wants to be able to help national authorities “in the shortest possible time frame”.
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