Posted by Michael Wonder on 07 Sep 2018
Tezepelumab granted breakthrough therapy designation by US FDA
7 September 2018 - AstraZeneca’s first breakthrough therapy designation for a respiratory medicine.
AstraZeneca and its partner Amgen today announced that 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. Currently-available biologic therapies only target Type 2-driven inflammation. Tezepelumab is a potential first-in-class new medicine that blocks thymic stromal lymphopoietin - an upstream modulator of multiple inflammatory pathways.
