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FDA Pulls EUA Granted to AstraZeneca's (AZN) Evusheld
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AstraZeneca (AZN - Free Report) announced that the FDA had withdrawn the authorization granted to Evusheld, its COVID-19 antibody combination, for use in the United States.
This decision is based on in vitro pseudovirus assay laboratory data which showed that Evusheld did not neutralize Omicron subvariants, which are responsible for more than 90% of current infections in the United States.
The FDA has indicated to AstraZeneca that it may reinstate Evusheld’s authorization if the national prevalence of resistant Omicron subvariants reduces to 90% or less sustainably.
Shares of AstraZeneca have gained 11.3% in the year compared to the industry’s 11.5% rise.
Image Source: Zacks Investment Research
Evusheld is a combination of two long-acting antibodies, namely tixagevimab and cilgavimab. Evusheld was previously authorized for pre-exposure prophylaxis of COVID-19 in certain high-risk populations in the United States.
In Europe and Japan, Evusheld is authorized for the prevention and treatment of COVID-19.
AstraZeneca is also evaluating its next-generation long-acting antibody for pre-exposure prophylaxis of COVID-19 in immunocompromised individuals in phase I/III study. Management intends to launch this antibody in second-half 2023.
In the present scenario, we note that the fate of antibody treatments in the United States is quite uncertain. Ever since last year began, several antibodies that were earlier granted authorization for emergency use by the FDA later got their status revoked. The FDA reiterated that these antibody treatments lack efficacy against the predominant Omicron variant.
In 2021, the FDA repealed the status of multiple COVID-19 antibody treatments. These include GSK (GSK - Free Report) /Vir Biotechnology’s (VIR - Free Report) sotrovimab and two separate antibody treatments developed by Eli Lilly (LLY - Free Report) .
Last year in April, Vir Biotechnology and partner GSK faced a major setback when the FDA determined that sotrovimab is no longer authorized to treat COVID-19, given its lack of efficacy against the Omicron variant. The news was a big blow to Vir Biotechnology and Glaxo as the revision would have affected sales of the antibody treatment.
Eli Lilly faced a similar obstacle in January 2022 when the FDA revised the EUA granted to bamlanivimab/etesevimab, its antibody cocktail. The regulatory agency cited that Eli Lilly’s antibody cocktail is unlikely to be effective against the Omicron variant. Last November, the FDA also rescinded the authorization granted to bebtelovimab, another antibody developed by Eli Lilly. The agency cited that the Eli Lilly antibody failed to Omicron subvariants BQ.1 and BQ.1.1.
In a separate press release, AstraZeneca announced that the European Commission had approved Enhertu for previously treated patients with unresectable or metastatic HER2-low metastatic breast cancer.
Enhertu is the first-ever HER2-directed medicine to demonstrate a significant survival benefit for treating patients with HER2-low metastatic breast cancer with both HR-positive and HR-negative disease. The approval was based on data from the pivotal phase III DESTINY-Breast04 study. Data from the study showed that Enhertu reduced the risk of disease progression or death by 50% and increased overall survival by more than six months compared to chemotherapy. The FDA approved Enhertu for the same patient population last August.
Image: Bigstock
FDA Pulls EUA Granted to AstraZeneca's (AZN) Evusheld
AstraZeneca (AZN - Free Report) announced that the FDA had withdrawn the authorization granted to Evusheld, its COVID-19 antibody combination, for use in the United States.
This decision is based on in vitro pseudovirus assay laboratory data which showed that Evusheld did not neutralize Omicron subvariants, which are responsible for more than 90% of current infections in the United States.
The FDA has indicated to AstraZeneca that it may reinstate Evusheld’s authorization if the national prevalence of resistant Omicron subvariants reduces to 90% or less sustainably.
Shares of AstraZeneca have gained 11.3% in the year compared to the industry’s 11.5% rise.
Image Source: Zacks Investment Research
Evusheld is a combination of two long-acting antibodies, namely tixagevimab and cilgavimab. Evusheld was previously authorized for pre-exposure prophylaxis of COVID-19 in certain high-risk populations in the United States.
In Europe and Japan, Evusheld is authorized for the prevention and treatment of COVID-19.
AstraZeneca is also evaluating its next-generation long-acting antibody for pre-exposure prophylaxis of COVID-19 in immunocompromised individuals in phase I/III study. Management intends to launch this antibody in second-half 2023.
In the present scenario, we note that the fate of antibody treatments in the United States is quite uncertain. Ever since last year began, several antibodies that were earlier granted authorization for emergency use by the FDA later got their status revoked. The FDA reiterated that these antibody treatments lack efficacy against the predominant Omicron variant.
In 2021, the FDA repealed the status of multiple COVID-19 antibody treatments. These include GSK (GSK - Free Report) /Vir Biotechnology’s (VIR - Free Report) sotrovimab and two separate antibody treatments developed by Eli Lilly (LLY - Free Report) .
Last year in April, Vir Biotechnology and partner GSK faced a major setback when the FDA determined that sotrovimab is no longer authorized to treat COVID-19, given its lack of efficacy against the Omicron variant. The news was a big blow to Vir Biotechnology and Glaxo as the revision would have affected sales of the antibody treatment.
Eli Lilly faced a similar obstacle in January 2022 when the FDA revised the EUA granted to bamlanivimab/etesevimab, its antibody cocktail. The regulatory agency cited that Eli Lilly’s antibody cocktail is unlikely to be effective against the Omicron variant. Last November, the FDA also rescinded the authorization granted to bebtelovimab, another antibody developed by Eli Lilly. The agency cited that the Eli Lilly antibody failed to Omicron subvariants BQ.1 and BQ.1.1.
In a separate press release, AstraZeneca announced that the European Commission had approved Enhertu for previously treated patients with unresectable or metastatic HER2-low metastatic breast cancer.
Enhertu is the first-ever HER2-directed medicine to demonstrate a significant survival benefit for treating patients with HER2-low metastatic breast cancer with both HR-positive and HR-negative disease. The approval was based on data from the pivotal phase III DESTINY-Breast04 study. Data from the study showed that Enhertu reduced the risk of disease progression or death by 50% and increased overall survival by more than six months compared to chemotherapy. The FDA approved Enhertu for the same patient population last August.
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AstraZeneca currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.