AstraZeneca gets 'breakthrough' designation for tezepelumab asthma treatment

7th Sep 2018 07:31

(Sharecast News) - AstraZeneca and its partner Amgen announced on Friday 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 or long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.The FTSE 100 pharmaceuticals giant said the designation was designed to expedite the development and regulatory review of medicines that were intended to treat a serious condition and that had showed "encouraging" early clinical results, which could demonstrate substantial improvement on a clinically-significant endpoint over available medicines.It said the designation was based on the tezepelumab Phase IIb 'PATHWAY' data, which 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 targeted T2-driven inflammation, AstraZeneca explained.It said tezepelumab was a potential first-in-class new medicine that blocked thymic stromal lymphopoietin - an upstream modulator of multiple inflammatory pathways."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," said AstraZeneca's executive vice president of global medicines development and chief medical officer Sean Bohen."The Breakthrough Therapy Designation will help us bring tezepelumab to patients as quickly as possible."AstraZeneca said it was the seventh Breakthrough Therapy Designation it had received from the FDA since 2014, and the first for the firm in respiratory medicine.Tezepelumab was currently in development in the Phase III PATHFINDER clinical trial programme.