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AstraZeneca seeks EUA for COVID-19 prophylaxis 

If authorized, the drug would be the first of its class.

By Brian Buntz | October 6, 2021

AstraZenecaAstraZeneca (LON:AZN) has filed paperwork with the FDA for an emergency use authorization (EUA) for AZD7442, a long-acting antibody (LAAB) cocktail, as a COVID-19 prophylaxis.

The paperwork filed for the EUA request includes data from the PROVENT and STORM CHASER Phase 3 trials.

A Phase 3 trial of AZD7442 showed statistically significant protection against COVID-19 infection. Compared to the placebo, the investigational drug offered 77% protection in the PROVENT trial against symptomatic disease compared to placebo.

The PROVENT study included 5,197 participants, with two-thirds receiving AZD7442 and the remainder getting placebo.

A single injection of AZD7442 could offer up to 12 months of protection from symptomatic SARS-CoV-2 infection.

The study also found that the drug was well-tolerated.

AstraZeneca foresees that the drug would be used alongside vaccines to protect vulnerable populations.

AZD7442 comprises two agents, tixagevimab (AZD8895) and cilgavimab (AZD1061), which were developed based on B-cells from COVID-19 patients.

There are currently no LAAB drugs that are authorized to prevent COVID-19 in the U.S.

AZD7442.

Last year, AstraZeneca won $486 million in funding from the U.S. government to pursue the development of AZD7442.


Filed Under: Infectious Disease
Tagged With: AstraZeneca, AZD1061, AZD7442, AZD8895, cilgavimab, COVID-19 therapies, COVID-19 vaccines, FDA, LAAB, long-acting antibody, PROVENT, STORM CHASER, tixagevimab
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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