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AstraZeneca (AZN) Gets EU Nod for COVID-19 Antibody Cocktail
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AstraZeneca PLC (AZN - Free Report) announced that the European Commission has granted marketing authorization to its long-acting cocktail antibody therapy, Evusheld, for pre-exposure prophylaxis (prevention) of COVID-19 infection in adults and adolescents aged 12 years and above and weighing at least 40 kg.
Formerly known as AZD7442, Evusheld is a combo of two monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061).
The approval in the European Union based on data from the PROVENT phase III pre-exposure prophylaxis study, which showed that treatment with Evusheld led to a 77% reduction in the risk of developing symptomatic COVID-19 versus placebo. It also demonstrated an 83% reduction at a six-month median analysis, with protection from the COVID-19 virus lasting for at least six months.
Per the press release, treatment with Evusheld retained neutralizing activity against the Omicron BA.2 subvariant, which is currently the dominant COVID-19 strain in Europe.
Last week, Evusheld was recommended for marketing authorization in the European Union for pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents aged 12 years and above with a weight of at least 40 kg.
Shares of AstraZeneca have rallied 11.8% so far this year compared with the industry’s increase of 2.5%.
Image Source: Zacks Investment Research
We remind investors that in December 2021, the FDA granted Emergency Use Authorization (“EUA”) to Evusheld for pre-exposure prophylaxis (prevention) of COVID-19 in some individuals.
The cocktail medicine is authorized for adults and adolescents (aged 12 and older) who are immunocompromised due to either a medical condition or immunosuppressive medications, those who cannot get sufficient immune response from COVID-19 vaccination, as well as for those who cannot get vaccinated. These individuals, however, should not have been exposed to the SARS-CoV-2 virus.
Following the EUA, Evusheld became the first cocktail antibody drug approved in the United States to prevent COVID-19 symptoms before virus exposure.
Earlier this month, Evusheld also received marketing authorization for the prevention of COVID-19 in Great Britain.
Please note that, recently, the FDA revised the EUA granted to Vir Biotech (VIR - Free Report) /GlaxoSmithKline’s (GSK - Free Report) monoclonal antibody, sotrovimab, for the treatment of COVID-19 infection.
The FDA’s decision to limit the EUA for Glaxo/Vir Biotechnology’s antibody therapy is based on new data, which showed that the treatment option was not effective against the Omicron BA.2 subvariant.
In January 2022, both Lilly and Regeneron (REGN - Free Report) faced a similar setback for their respective antibody cocktails for COVID-19 treatment.
The FDA revised the EUA granted to the antibody cocktails developed by Lilly and Regeneron based on data showing that the treatments are unlikely to be effective against the Omicron variant.
Image: Bigstock
AstraZeneca (AZN) Gets EU Nod for COVID-19 Antibody Cocktail
AstraZeneca PLC (AZN - Free Report) announced that the European Commission has granted marketing authorization to its long-acting cocktail antibody therapy, Evusheld, for pre-exposure prophylaxis (prevention) of COVID-19 infection in adults and adolescents aged 12 years and above and weighing at least 40 kg.
Formerly known as AZD7442, Evusheld is a combo of two monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061).
The approval in the European Union based on data from the PROVENT phase III pre-exposure prophylaxis study, which showed that treatment with Evusheld led to a 77% reduction in the risk of developing symptomatic COVID-19 versus placebo. It also demonstrated an 83% reduction at a six-month median analysis, with protection from the COVID-19 virus lasting for at least six months.
Per the press release, treatment with Evusheld retained neutralizing activity against the Omicron BA.2 subvariant, which is currently the dominant COVID-19 strain in Europe.
Last week, Evusheld was recommended for marketing authorization in the European Union for pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents aged 12 years and above with a weight of at least 40 kg.
Shares of AstraZeneca have rallied 11.8% so far this year compared with the industry’s increase of 2.5%.
Image Source: Zacks Investment Research
We remind investors that in December 2021, the FDA granted Emergency Use Authorization (“EUA”) to Evusheld for pre-exposure prophylaxis (prevention) of COVID-19 in some individuals.
The cocktail medicine is authorized for adults and adolescents (aged 12 and older) who are immunocompromised due to either a medical condition or immunosuppressive medications, those who cannot get sufficient immune response from COVID-19 vaccination, as well as for those who cannot get vaccinated. These individuals, however, should not have been exposed to the SARS-CoV-2 virus.
Following the EUA, Evusheld became the first cocktail antibody drug approved in the United States to prevent COVID-19 symptoms before virus exposure.
Earlier this month, Evusheld also received marketing authorization for the prevention of COVID-19 in Great Britain.
Please note that, recently, the FDA revised the EUA granted to Vir Biotech (VIR - Free Report) /GlaxoSmithKline’s (GSK - Free Report) monoclonal antibody, sotrovimab, for the treatment of COVID-19 infection.
The FDA’s decision to limit the EUA for Glaxo/Vir Biotechnology’s antibody therapy is based on new data, which showed that the treatment option was not effective against the Omicron BA.2 subvariant.
In January 2022, both Lilly and Regeneron (REGN - Free Report) faced a similar setback for their respective antibody cocktails for COVID-19 treatment.
The FDA revised the EUA granted to the antibody cocktails developed by Lilly and Regeneron based on data showing that the treatments are unlikely to be effective against the Omicron variant.
Zacks Rank
AstraZeneca currently carries a Zacks Rank of #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.