First modification:
The European Medicines Agency (EMA) endorsed the authorization of the use of the antiviral Paxlovid, from the pharmaceutical company Pfizer, to treat adults at risk of developing serious illness from Covid-19. The support of the regulatory body comes at a time when the continent is striving to increase its health arsenal to combat the Omicron variant.
Paxlovid will become the first oral antiviral in the European Union to prevent hospitalizations for Covid-19.
In a statement issued this Thursday, January 27, the EU medicines regulator gave the green light to the use of the medicine from the pharmaceutical company Pfizer to help prevent the development of a serious illness as a result of the virus.
The European Medicines Agency (EMA) expert committee recommended that the pill be given to adults who do not require oxygen but are at higher risk of severe symptoms.
EU Health Commissioner Stella Kyriakides said the 27-country bloc is now seeing good progress in aligning treatments, which she described as a second line of defense after vaccines.
“Paxlovid is the first oral antiviral for home use in our portfolio and has the potential to make a real difference for people at high risk of progression to severe Covid-19,” Kyriakides said, following the approval of the drug.
The EMA indicated that its decision was made based on a review of the use of the drug in people who, for the most part, were infected with the Delta variant, but believes that it would also be useful to curb the current increase in transmissibility caused by Ómicron, much more contagious.
Studies indicate 90% efficacy in preventing hospitalizations and deaths
Paxlovid, a two-drug antiviral regimen, was nearly 90% effective in preventing hospitalizations and deaths in patients at high risk for severe disease, according to clinical trial data from the US-based laboratory. Recent data from the company also suggests that it remains effective against Omicron.
“Based on laboratory studies, Paxlovid is also expected to be active against Omicron and other variants,” the agency said, adding that the drug’s safety level is “favorable” and side effects are generally mild.
The EMA had already licensed Paxlovid on December 16, but only for emergencies and under the decision of the authorities of each country.
In the United States and the United Kingdom, the oral antiviral was authorized at the end of last December, although the authorities of those countries indicated that supplies would be extremely limited.
“A real ray of hope”
Now it is in the hands of the European Commission if it endorses the use of Paxlovid to prevent serious symptoms, although it is a usual step after the recommendations of the drug regulatory body.
Peter Liese, the European Parliament’s health spokesman, called the EMA’s backing a “real ray of hope” for a return to normalcy after the pandemic. But he cautioned that there were no guarantees from the European Commission or member countries that the drug would be distributed quickly.
An antiviral pill from the German laboratory Merck is also expected to be licensed soon.
Still, experts say the Pfizer drug is almost certainly the preferred choice because of its mild side effects and superior efficacy, as studies suggest.
The pills from Pfizer and Merck are expected to be effective against Omicron, because they do not target the spike protein where most of the variant’s concerning mutations reside.
Paxlovid contains two active substances, PF-07321332 and ritonavir, which are given as two different tablets to be taken once every 24 hours for five days.
The first active ingredient reduces the ability of the virus to multiply in the body, while the second prolongs the action of PF-07321332, that is, it allows it to remain in the body for longer.
With Reuters and AP
First modification:
The European Medicines Agency (EMA) endorsed the authorization of the use of the antiviral Paxlovid, from the pharmaceutical company Pfizer, to treat adults at risk of developing serious illness from Covid-19. The support of the regulatory body comes at a time when the continent is striving to increase its health arsenal to combat the Omicron variant.
Paxlovid will become the first oral antiviral in the European Union to prevent hospitalizations for Covid-19.
In a statement issued this Thursday, January 27, the EU medicines regulator gave the green light to the use of the medicine from the pharmaceutical company Pfizer to help prevent the development of a serious illness as a result of the virus.
The European Medicines Agency (EMA) expert committee recommended that the pill be given to adults who do not require oxygen but are at higher risk of severe symptoms.
EU Health Commissioner Stella Kyriakides said the 27-country bloc is now seeing good progress in aligning treatments, which she described as a second line of defense after vaccines.
“Paxlovid is the first oral antiviral for home use in our portfolio and has the potential to make a real difference for people at high risk of progression to severe Covid-19,” Kyriakides said, following the approval of the drug.
The EMA indicated that its decision was made based on a review of the use of the drug in people who, for the most part, were infected with the Delta variant, but believes that it would also be useful to curb the current increase in transmissibility caused by Ómicron, much more contagious.
Studies indicate 90% efficacy in preventing hospitalizations and deaths
Paxlovid, a two-drug antiviral regimen, was nearly 90% effective in preventing hospitalizations and deaths in patients at high risk for severe disease, according to clinical trial data from the US-based laboratory. Recent data from the company also suggests that it remains effective against Omicron.
“Based on laboratory studies, Paxlovid is also expected to be active against Omicron and other variants,” the agency said, adding that the drug’s safety level is “favorable” and side effects are generally mild.
The EMA had already licensed Paxlovid on December 16, but only for emergencies and under the decision of the authorities of each country.
In the United States and the United Kingdom, the oral antiviral was authorized at the end of last December, although the authorities of those countries indicated that supplies would be extremely limited.
“A real ray of hope”
Now it is in the hands of the European Commission if it endorses the use of Paxlovid to prevent serious symptoms, although it is a usual step after the recommendations of the drug regulatory body.
Peter Liese, the European Parliament’s health spokesman, called the EMA’s backing a “real ray of hope” for a return to normalcy after the pandemic. But he cautioned that there were no guarantees from the European Commission or member countries that the drug would be distributed quickly.
An antiviral pill from the German laboratory Merck is also expected to be licensed soon.
Still, experts say the Pfizer drug is almost certainly the preferred choice because of its mild side effects and superior efficacy, as studies suggest.
The pills from Pfizer and Merck are expected to be effective against Omicron, because they do not target the spike protein where most of the variant’s concerning mutations reside.
Paxlovid contains two active substances, PF-07321332 and ritonavir, which are given as two different tablets to be taken once every 24 hours for five days.
The first active ingredient reduces the ability of the virus to multiply in the body, while the second prolongs the action of PF-07321332, that is, it allows it to remain in the body for longer.
With Reuters and AP
First modification:
The European Medicines Agency (EMA) endorsed the authorization of the use of the antiviral Paxlovid, from the pharmaceutical company Pfizer, to treat adults at risk of developing serious illness from Covid-19. The support of the regulatory body comes at a time when the continent is striving to increase its health arsenal to combat the Omicron variant.
Paxlovid will become the first oral antiviral in the European Union to prevent hospitalizations for Covid-19.
In a statement issued this Thursday, January 27, the EU medicines regulator gave the green light to the use of the medicine from the pharmaceutical company Pfizer to help prevent the development of a serious illness as a result of the virus.
The European Medicines Agency (EMA) expert committee recommended that the pill be given to adults who do not require oxygen but are at higher risk of severe symptoms.
EU Health Commissioner Stella Kyriakides said the 27-country bloc is now seeing good progress in aligning treatments, which she described as a second line of defense after vaccines.
“Paxlovid is the first oral antiviral for home use in our portfolio and has the potential to make a real difference for people at high risk of progression to severe Covid-19,” Kyriakides said, following the approval of the drug.
The EMA indicated that its decision was made based on a review of the use of the drug in people who, for the most part, were infected with the Delta variant, but believes that it would also be useful to curb the current increase in transmissibility caused by Ómicron, much more contagious.
Studies indicate 90% efficacy in preventing hospitalizations and deaths
Paxlovid, a two-drug antiviral regimen, was nearly 90% effective in preventing hospitalizations and deaths in patients at high risk for severe disease, according to clinical trial data from the US-based laboratory. Recent data from the company also suggests that it remains effective against Omicron.
“Based on laboratory studies, Paxlovid is also expected to be active against Omicron and other variants,” the agency said, adding that the drug’s safety level is “favorable” and side effects are generally mild.
The EMA had already licensed Paxlovid on December 16, but only for emergencies and under the decision of the authorities of each country.
In the United States and the United Kingdom, the oral antiviral was authorized at the end of last December, although the authorities of those countries indicated that supplies would be extremely limited.
“A real ray of hope”
Now it is in the hands of the European Commission if it endorses the use of Paxlovid to prevent serious symptoms, although it is a usual step after the recommendations of the drug regulatory body.
Peter Liese, the European Parliament’s health spokesman, called the EMA’s backing a “real ray of hope” for a return to normalcy after the pandemic. But he cautioned that there were no guarantees from the European Commission or member countries that the drug would be distributed quickly.
An antiviral pill from the German laboratory Merck is also expected to be licensed soon.
Still, experts say the Pfizer drug is almost certainly the preferred choice because of its mild side effects and superior efficacy, as studies suggest.
The pills from Pfizer and Merck are expected to be effective against Omicron, because they do not target the spike protein where most of the variant’s concerning mutations reside.
Paxlovid contains two active substances, PF-07321332 and ritonavir, which are given as two different tablets to be taken once every 24 hours for five days.
The first active ingredient reduces the ability of the virus to multiply in the body, while the second prolongs the action of PF-07321332, that is, it allows it to remain in the body for longer.
With Reuters and AP
First modification:
The European Medicines Agency (EMA) endorsed the authorization of the use of the antiviral Paxlovid, from the pharmaceutical company Pfizer, to treat adults at risk of developing serious illness from Covid-19. The support of the regulatory body comes at a time when the continent is striving to increase its health arsenal to combat the Omicron variant.
Paxlovid will become the first oral antiviral in the European Union to prevent hospitalizations for Covid-19.
In a statement issued this Thursday, January 27, the EU medicines regulator gave the green light to the use of the medicine from the pharmaceutical company Pfizer to help prevent the development of a serious illness as a result of the virus.
The European Medicines Agency (EMA) expert committee recommended that the pill be given to adults who do not require oxygen but are at higher risk of severe symptoms.
EU Health Commissioner Stella Kyriakides said the 27-country bloc is now seeing good progress in aligning treatments, which she described as a second line of defense after vaccines.
“Paxlovid is the first oral antiviral for home use in our portfolio and has the potential to make a real difference for people at high risk of progression to severe Covid-19,” Kyriakides said, following the approval of the drug.
The EMA indicated that its decision was made based on a review of the use of the drug in people who, for the most part, were infected with the Delta variant, but believes that it would also be useful to curb the current increase in transmissibility caused by Ómicron, much more contagious.
Studies indicate 90% efficacy in preventing hospitalizations and deaths
Paxlovid, a two-drug antiviral regimen, was nearly 90% effective in preventing hospitalizations and deaths in patients at high risk for severe disease, according to clinical trial data from the US-based laboratory. Recent data from the company also suggests that it remains effective against Omicron.
“Based on laboratory studies, Paxlovid is also expected to be active against Omicron and other variants,” the agency said, adding that the drug’s safety level is “favorable” and side effects are generally mild.
The EMA had already licensed Paxlovid on December 16, but only for emergencies and under the decision of the authorities of each country.
In the United States and the United Kingdom, the oral antiviral was authorized at the end of last December, although the authorities of those countries indicated that supplies would be extremely limited.
“A real ray of hope”
Now it is in the hands of the European Commission if it endorses the use of Paxlovid to prevent serious symptoms, although it is a usual step after the recommendations of the drug regulatory body.
Peter Liese, the European Parliament’s health spokesman, called the EMA’s backing a “real ray of hope” for a return to normalcy after the pandemic. But he cautioned that there were no guarantees from the European Commission or member countries that the drug would be distributed quickly.
An antiviral pill from the German laboratory Merck is also expected to be licensed soon.
Still, experts say the Pfizer drug is almost certainly the preferred choice because of its mild side effects and superior efficacy, as studies suggest.
The pills from Pfizer and Merck are expected to be effective against Omicron, because they do not target the spike protein where most of the variant’s concerning mutations reside.
Paxlovid contains two active substances, PF-07321332 and ritonavir, which are given as two different tablets to be taken once every 24 hours for five days.
The first active ingredient reduces the ability of the virus to multiply in the body, while the second prolongs the action of PF-07321332, that is, it allows it to remain in the body for longer.
With Reuters and AP