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Breakthrough designation AstraZeneca’s severe asthma drug

September 07, 2018 / Piotr Wnuk

The first-in-class medicine for severe asthma co-developed by AstraZeneca and Amgen is poised for accelerated approval after the US Food and Drug Administration granted it a breakthrough designation.
AstraZeneca and its development partner Amgen announced that the FDA has granted Breakthrough Therapy Designation (BTD) 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.