Amgen, AstraZeneca's tezepelumab meets primary endpoint in late-stage asthma study

• Amgen (NASDAQ:AMGN) and AstraZeneca (NASDAQ:AZN) announce positive topline results from the Phase 3 NAVIGATOR trial evaluating investigational medicine tezepelumab compared to placebo in patients with severe asthma.
• The NAVIGATOR trial met the primary endpoint with tezepelumab added to standard of care (SoC) demonstrating a statistically significant and clinically meaningful reduction compared to placebo plus SoC in the annualized asthma exacerbation rate (AAER) over 52 weeks in the overall patient population, regardless of eosinophil count.
• SoC was medium or high dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without oral corticosteroids (OCS).
• Tezepelumab was very well tolerated and preliminary analyses show no clinically meaningful differences in safety results between the tezepelumab and placebo groups.
• Tezepelumab blocks the action of thymic stromal lymphopoietin, an epithelial cytokine that plays a key role across the spectrum of asthma inflammation.
• Results from the NAVIGATOR trial will be presented at an upcoming medical meeting.
• Earlier in 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Both companies will continue to share costs and profits equally after payment of mid-single-digit royalty to Amgen.
• AstraZeneca continues to lead development and Amgen continues to lead manufacturing.
• https://seekingalpha.com/news/3634177-amgen-and-astrazenecas-tezepelumab-meets-primary-endpoint-in-late-stage-asthma-study