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AstraZeneca (AZN) Gets FDA Nod for COVID Prevention Drug
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AstraZeneca (AZN - Free Report) announced that the FDA has granted Emergency Use Authorization (EUA) to its investigational long-acting cocktail antibody therapy, AZD7442, 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 a medical condition or immunosuppressive medications or those who cannot get sufficient immune response from COVID-19 vaccination or those who cannot get vaccinated. These individuals, however, should not have been exposed to the SARS-CoV-2 virus.
AZD7442, to be marketed by the brand name Evusheld, is a combo of two monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061)
With emergency approval from the FDA, AstraZeneca’s (AZN - Free Report) Evusheld is the first cocktail antibody drug approved in the United States to prevent COVID-19 symptoms before virus exposure. AstraZeneca has a deal in place to supply 700,000 doses of Evusheld to the U.S. government. The first doses of the medicine are expected to be available soon
AstraZeneca said that Evusheld works against all previous COVID variants. AstraZeneca is working to show that it neutralizes the Omicron variant too.
This year so far, AZN’s shares are up 13.2% compared with an increase of 16.8% for the industry.
Image Source: Zacks Investment Research
The approval was primarily based on data from the PROVENT phase III pre-exposure prophylaxis study, which showed that Evusheld led to a statistically significant reduction in the incidence of symptomatic COVID-19. In the study, Evusheld reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo. The FDA filing for COVID-19 prevention also included relevant data from the STORM CHASER phase III study.
Evusheld is also being evaluated in the TACKLE phase III outpatient treatment study. Data from the TACKLE study announced last month showed that one 600mg intramuscular dose of Evusheld reduced the risk of severe COVID-19 or death by 88% compared to placebo when patients were treated within three days of symptom onset. Evusheld is also being studied as a potential treatment for hospitalized COVID-19 patients as part of the National Institute of Health’s ACTIV-3 trial.
AstraZeneca believes Evusheld provides an option to protect against COVID-19 alongside vaccines, especially for vulnerable populations such as those who do not have strong immune systems. Please note that AstraZeneca’s COVID-19 vaccine is not yet approved in the United States though it is available in several other countries including the European Union.
At present, monoclonal antibody medicines of Eli Lilly (LLY - Free Report) , Regeneron (REGN - Free Report) , and Vir Biotech/GlaxoSmithKline (GSK - Free Report) are available in the United States to treat COVID-19.
Lilly’s COVID-19 antibody cocktail, bamlanivimab plus etesevimab has EUA both for the treatment of patients with COVID-19 as well as for post-exposure prophylaxis in high-risk individuals of any age.
Lilly’s cocktail medicine generated revenues of $217.1 million in the third quarter of 2021.
Regeneron’s antibody cocktail, REGEN-COV comprises two monoclonal antibodies, casirivimab and imdevimab and has become a significant contributor to its top line in recent quarters.
Regeneron’s REGEN-COV generated total sales of $1.2 billion in the third quarter of 2021.
Glaxo and Vir Biotech’s Xevudy (sotrovimab) was granted emergency approval by the FDA in May 2021 for treating high-risk COVID-19.
Xevudy contributed 3 percentage points of growth to Glaxo’s total Pharmaceutical sales in the third quarter of 2021. Sotrovimab is not yet approved in Europe though Glaxo and VIR Biotech have a joint procurement agreement with the European Commission to supply up to 220,000 doses of sotrovimab, once it is authorized in Europe.
Image: Bigstock
AstraZeneca (AZN) Gets FDA Nod for COVID Prevention Drug
AstraZeneca (AZN - Free Report) announced that the FDA has granted Emergency Use Authorization (EUA) to its investigational long-acting cocktail antibody therapy, AZD7442, 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 a medical condition or immunosuppressive medications or those who cannot get sufficient immune response from COVID-19 vaccination or those who cannot get vaccinated. These individuals, however, should not have been exposed to the SARS-CoV-2 virus.
AZD7442, to be marketed by the brand name Evusheld, is a combo of two monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061)
With emergency approval from the FDA, AstraZeneca’s (AZN - Free Report) Evusheld is the first cocktail antibody drug approved in the United States to prevent COVID-19 symptoms before virus exposure. AstraZeneca has a deal in place to supply 700,000 doses of Evusheld to the U.S. government. The first doses of the medicine are expected to be available soon
AstraZeneca said that Evusheld works against all previous COVID variants. AstraZeneca is working to show that it neutralizes the Omicron variant too.
This year so far, AZN’s shares are up 13.2% compared with an increase of 16.8% for the industry.
The approval was primarily based on data from the PROVENT phase III pre-exposure prophylaxis study, which showed that Evusheld led to a statistically significant reduction in the incidence of symptomatic COVID-19. In the study, Evusheld reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo. The FDA filing for COVID-19 prevention also included relevant data from the STORM CHASER phase III study.
Evusheld is also being evaluated in the TACKLE phase III outpatient treatment study. Data from the TACKLE study announced last month showed that one 600mg intramuscular dose of Evusheld reduced the risk of severe COVID-19 or death by 88% compared to placebo when patients were treated within three days of symptom onset. Evusheld is also being studied as a potential treatment for hospitalized COVID-19 patients as part of the National Institute of Health’s ACTIV-3 trial.
AstraZeneca believes Evusheld provides an option to protect against COVID-19 alongside vaccines, especially for vulnerable populations such as those who do not have strong immune systems. Please note that AstraZeneca’s COVID-19 vaccine is not yet approved in the United States though it is available in several other countries including the European Union.
At present, monoclonal antibody medicines of Eli Lilly (LLY - Free Report) , Regeneron (REGN - Free Report) , and Vir Biotech/GlaxoSmithKline (GSK - Free Report) are available in the United States to treat COVID-19.
Lilly’s COVID-19 antibody cocktail, bamlanivimab plus etesevimab has EUA both for the treatment of patients with COVID-19 as well as for post-exposure prophylaxis in high-risk individuals of any age.
Lilly’s cocktail medicine generated revenues of $217.1 million in the third quarter of 2021.
Regeneron’s antibody cocktail, REGEN-COV comprises two monoclonal antibodies, casirivimab and imdevimab and has become a significant contributor to its top line in recent quarters.
Regeneron’s REGEN-COV generated total sales of $1.2 billion in the third quarter of 2021.
Glaxo and Vir Biotech’s Xevudy (sotrovimab) was granted emergency approval by the FDA in May 2021 for treating high-risk COVID-19.
Xevudy contributed 3 percentage points of growth to Glaxo’s total Pharmaceutical sales in the third quarter of 2021. Sotrovimab is not yet approved in Europe though Glaxo and VIR Biotech have a joint procurement agreement with the European Commission to supply up to 220,000 doses of sotrovimab, once it is authorized in Europe.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.