FDA Awards AstraZeneca and Amgen’s Tezepelumab Breakthrough Designation

The FDA granted breakthrough designation for AstraZeneca and partner Amgen’s severe asthma treatment, tezepelumab, marking AstraZeneca’s first breakthrough designation in respiratory medicine.

The treatment is for patients without an eosinophilic phenotype that are receiving inhaled corticosteroids/long acting beta2-agonists with or without corticosteroids and additional asthma controllers.

The agency’s decision to grant the drug an expedited review was based on Phase IIb Pathway data, which showed a notable reduction in the annual asthma exacerbation rate compared to placebo in a large population of severe asthma patients. The drug is currently in Phase III clinical trials.