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For tezepelumab in patients with severe asthma without an eosinophilic phenotype
September 7, 2018
By: Betsy Louda
Amgen and AstraZeneca announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype. The Breakthrough Therapy Designation is supported by the tezepelumab Phase 2b PATHWAY data. The trial showed a significant reduction in the annual asthma exacerbation rate compared with placebo in a broad population of severe asthma patients independent of baseline blood eosinophil count or other type 2 (T2) inflammatory biomarkers. 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. “The Phase 2b PATHWAY trial data demonstrated tezepelumab’s promise as a novel therapeutic option for a broad population of patients with severe asthma, including those ineligible for currently approved biologic therapies,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “The Breakthrough Designation will give us the opportunity to work closely with the FDA to bring tezepelumab to patients as quickly as possible.” Tezepelumab is currently in development in the Phase 3 PATHFINDER clinical trial program.
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