AstraZeneca’s Tezepelumab (thymic stromal lymphopoietin antagonist) Receives FDA BT Designation for the Treatment of Severe Asthma with irrespective T2 biomarker status

Shots:

•  The designation is based on P-IIb PATHWAY assessing (tezepelumab vs PBO) in patients with asthma exacerbations, uncontrolled asthma receiving inhaled corticosteroids/LA- β2-agonists w/o oral corticosteroids and additional asthma controllers
•  P-IIb PATHWAY involves administering of (70/210mg q4w or 280mg q2w) which showed reduction in annual asthma exacerbation rate reductions of 62%, 71% and 66% vs PBO
• AZ received seven BT designation since 2014, with first in respiratory and tezepelumab is under P-III PATHFINDER clinical trial programme

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