AstraZeneca asthma treatment Tezepelumab license application accepted

(Alliance News) - AstraZeneca PLC on Thursday said it has had a Biologics License Application ...

Alliance News 8 July, 2021 | 9:06AM
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(Alliance News) - AstraZeneca PLC on Thursday said it has had a Biologics License Application accepted for its asthma treatment Tezepelumab.

Tezepelumab also has been granted priority review from the US Food & Drug Administration. The FDA only grants this for medicines offering significant advantages over other options due to "safety or efficacy improvements, preventing serious conditions or enhancing patient compliance".

The severe asthma treatment is being developed alongside California-based biopharmaceutical firm Amgen Inc.

AstraZeneca claims the drug is the only biologic to consistently reduce asthma exacerbations across phase 2 and 3 clinical trials.

"This decision brings us a step closer to delivering a much-needed, first-in-class medicine for asthma patients, many of whom remain uncontrolled and at risk of asthma attacks despite the availability of inhaled and biologic medicines," commented Mene Pangalos, executive vice president of BioPharmaceuticals research & development.

AstraZeneca shares were trading down 0.7% at 8,595.00 pence each in London on Thursday morning. Amgen shares closed down 0.2% in New York on Wednesday at USD243.22.

By Will Paige; willpaige@alliancenews.com

Copyright 2021 Alliance News Limited. All Rights Reserved.

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Securities Mentioned in Article

Security Name Price Change (%) Morningstar
Rating
AstraZeneca PLC 8,585.00 GBX -1.44
Amgen Inc 214.45 USD -0.42

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