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Tezepelumab regulatory submission accepted and granted FDA Priority Review

Date Time Tezepelumab regulatory submission accepted and granted FDA Priority Review AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). Tezepelumab is being developed by AstraZeneca in collaboration with Amgen. The FDA grants Priority Review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. 1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2022. Despite recent advances in severe asthma, many patients may not qualify for or respond well to current biologic medicines.

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