> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Positive Trial Results for Amgen’s Tezepelumab
- URL: https://www.fdaweb.com/positive-trial-results-for-amgens-tezepelumab/
- Published: 2020-11-10T12:00:00.000Z
- Updated: 2026-09-14T16:35:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148051

Amgen and AstraZeneca say their investigational asthma drug tezepelumab achieved positive topline results in the Phase 3 NAVIGATOR trial. A [statement](https://www.amgen.com/media/news-releases/2020/11/tezepelumab-navigator-phase-3-trial-met-primary-endpoint-of-a-statistically-significant-and-clinically-meaningful-reduction-in-exacerbations-in-a-broad-population-of-patients-with-severe-asthma/?ref=fdaweb.com) from the companies says tezepelumab demonstrated a statistically significant reduction in exacerbations compared to placebo in patients with severe asthma.

The statement says the drug was very well tolerated in patients with severe asthma and preliminary analyses showed no meaningful differences in safety results between the tezepelumab and placebo groups.

The statement describes tezepelumab as “a potential first-in-class medicine that blocks the action of the thymic stromal lymphopoletin (TSLP), an epithelial cytokine that plays a key role across the spectrum of asthma inflammation. NAVIGATOR is the first Phase 3 trial to show benefit in severe asthma by targeting TSLP.”