USA – AstraZeneca, Amgen’s tezepelumab wins ‘breakthrough’ status

AstraZeneca and Amgen’s tezepelumab has won breakthrough therapy status in the US for its potential to treat severe asthma without an eosinophilic phenotype.

The therapy is being developed for use in patients who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.

The breakthrough designation is based on data from the Phase IIb PATHWAY trial, which, according to the firms, 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 (T2) biomarker status”.

T2 inflammation-driven asthma, which includes the eosinophilic phenotype, accounts for around two-thirds of severe asthma cases and is typically characterised by elevated levels of T2 inflammatory biomarkers…