Tezepelumab granted Breakthrough Therapy Designation by US FDA
AstraZeneca and its partner Amgen Inc. announced that the US Food and Drug Administration (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.
A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically-significant endpoint over available medicines.
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 (T2) biomarker status. Currently-available biologic therapies only target T2-driven inflammation. Tezepelumab is a potential first-in-class new medicine that blocks thymic stromal lymphopoietin (TSLP) – an upstream modulator of multiple inflammatory pathways.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Tezepelumab is exciting because it has the potential to treat a broad population of severe asthma patients, including those ineligible for currently-approved biologic therapies. The Breakthrough Therapy Designation will help us bring tezepelumab to patients as quickly as possible.”
This is the seventh Breakthrough Therapy Designation that AstraZeneca has received from the FDA since 2014, and the first for the Company in respiratory medicine. Tezepelumab is currently in development in the Phase III PATHFINDER clinical trial programme.