Breaking News, Collaborations & Alliances, Trials & Filings

FDA Grants Amgen & AstraZeneca Breakthrough Therapy Designation

For tezepelumab in patients with severe asthma without an eosinophilic phenotype

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 ot...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters