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AstraZeneca, Amgen Announce Breakthrough Therapy Designation For Tezepelumab

AstraZeneca and Amgen Inc. (AMGN) announced the US FDA has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.

The Breakthrough Therapy Designation is based on the tezepelumab Phase IIb PATHWAY data that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in a broad population of severe asthma patients irrespective of patient phenotype including Type 2 biomarker status.

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