Amgen, AstraZeneca strengthen case for approval of tezepelumab in severe asthma

Amgen and AstraZeneca on Thursday reported further results from a Phase III study of tezepelumab in patients with severe asthma, with the TSLP targeting monoclonal antibody showing superiority compared to placebo across four patient subgroups. The data were published in the NEJM and are scheduled to be presented at the American Thoracic Society (ATS) conference.

The companies announced in November last year that the NAVIGATOR trial achieved its primary endpoint by demonstrating a significant and clinically meaningful reduction in the annualised asthma exacerbation rate (AAER) over 52 weeks compared to placebo plus standard care. Results released earlier this year showed that the addition of tezepelumab to standard care treatment reduced AAERs by 56% in patients with severe, uncontrolled asthma, compared to placebo, with benefits seen regardless of baseline eosinophil count.

The latest data showed that in patients with elevated baseline blood eosinophil counts and fractional exhaled nitric oxide (FeNO) levels, tezepelumab achieved a clinically meaningful 77% reduction in the AAER, compared to placebo. Meanwhile, in a separate exploratory analysis of exacerbations requiring hospitalisations, tezepelumab showed an 85% reduction over 52 weeks compared to placebo when added to standard of care.

Earlier this week, AstraZeneca submitted an application to the FDA seeking approval of tezepelumab.

May 13th, 2021

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