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AstraZeneca (AZN) Seeks Emergency Nod for COVID Prevention Drug
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AstraZeneca (AZN - Free Report) has filed an application seeking Emergency Use Authorization (EUA) for its investigational long-acting cocktail antibody therapy, AZD7442 for prophylaxis of symptomatic COVID-19. If authorized by the FDA, AZD7442 would be the first such cocktail antibody drug approved for COVID-19 prevention.
The application was based on data from the PROVENT phase III pre-exposure prophylaxis study, which showed that AZD7442 led to a statistically significant reduction in the incidence of symptomatic COVID-19. In the study, AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo.
This year so far, AstraZeneca’s shares are up 21.1% compared with an increase of 8% for the industry.
Image Source: Zacks Investment Research
In June, however, a phase III study on AZD7442, for the post-exposure prevention of symptomatic COVID-19, failed to meet the primary endpoint. In the study called STORM CHASER, AZD7442 failed to show a statistically significant reduction in the risk of developing symptomatic COVID-19 in adult unvaccinated study participants who had a confirmed exposure to a person with a case of the SARS-CoV-2 virus within the past eight days. However, data from a pre-planned subgroup analysis of participants who were PCR negative at time of dosing in the study showed that treatment with AZD7442 reduced the risk of developing symptomatic COVID-19 by 73% compared with placebo. The FDA filing for COVID-19 prevention also included relevant data from the STORM CHASER phase III study.
AZD7442 is a combo of two monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061) Another study, TACKLE is also ongoing on AZD7442. It is a treatment study for mild-to-moderate COVID-19 in the outpatient setting.
AstraZeneca believes AZD7442 provides an option to protect against COVD-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 (VIR - Free Report) /GlaxoSmithKline are available in the United States to treat COVID-19.
In a separate press release, AstraZeneca announced that the FDA has granted Breakthrough Therapy designation to it and partner Daiichi Sankyo’s drug Enhertu for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens. The prestigious status was based on data from the head-to-head DESTINY-Breast03 phase III study, which showed that Enhertu reduced the risk of death or tumor progression by 72% in patients with HER2-positive metastatic breast cancer previously treated with Roche’s Kadcyla (trastuzumab emtansine [T-DM1]) and a taxane.
Enhertu is presently approved to treat unresectable or metastatic HER2-positive breast cancer in patients who have received two or more prior anti-HER2-based regimens. The drug is also approved to treat HER2+ metastatic gastric cancer.
Image: Bigstock
AstraZeneca (AZN) Seeks Emergency Nod for COVID Prevention Drug
AstraZeneca (AZN - Free Report) has filed an application seeking Emergency Use Authorization (EUA) for its investigational long-acting cocktail antibody therapy, AZD7442 for prophylaxis of symptomatic COVID-19. If authorized by the FDA, AZD7442 would be the first such cocktail antibody drug approved for COVID-19 prevention.
The application was based on data from the PROVENT phase III pre-exposure prophylaxis study, which showed that AZD7442 led to a statistically significant reduction in the incidence of symptomatic COVID-19. In the study, AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo.
This year so far, AstraZeneca’s shares are up 21.1% compared with an increase of 8% for the industry.
In June, however, a phase III study on AZD7442, for the post-exposure prevention of symptomatic COVID-19, failed to meet the primary endpoint. In the study called STORM CHASER, AZD7442 failed to show a statistically significant reduction in the risk of developing symptomatic COVID-19 in adult unvaccinated study participants who had a confirmed exposure to a person with a case of the SARS-CoV-2 virus within the past eight days. However, data from a pre-planned subgroup analysis of participants who were PCR negative at time of dosing in the study showed that treatment with AZD7442 reduced the risk of developing symptomatic COVID-19 by 73% compared with placebo. The FDA filing for COVID-19 prevention also included relevant data from the STORM CHASER phase III study.
AZD7442 is a combo of two monoclonal antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061) Another study, TACKLE is also ongoing on AZD7442. It is a treatment study for mild-to-moderate COVID-19 in the outpatient setting.
AstraZeneca believes AZD7442 provides an option to protect against COVD-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 (VIR - Free Report) /GlaxoSmithKline are available in the United States to treat COVID-19.
In a separate press release, AstraZeneca announced that the FDA has granted Breakthrough Therapy designation to it and partner Daiichi Sankyo’s drug Enhertu for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens. The prestigious status was based on data from the head-to-head DESTINY-Breast03 phase III study, which showed that Enhertu reduced the risk of death or tumor progression by 72% in patients with HER2-positive metastatic breast cancer previously treated with Roche’s Kadcyla (trastuzumab emtansine [T-DM1]) and a taxane.
Enhertu is presently approved to treat unresectable or metastatic HER2-positive breast cancer in patients who have received two or more prior anti-HER2-based regimens. The drug is also approved to treat HER2+ metastatic gastric cancer.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.