It was already known that Amgen/Astrazeneca’s tezepelumab had performed well in patients with non-eosinophilic asthma in the pivotal Navigator trial – the question was how well. Now detailed data, to be presented at the upcoming AAAAI meeting, show a convincing 41% reduction in annual asthma exacerbations with the TSLP inhibitor in this underserved asthma subpopulation. And the performance was similar in very low-eosinophil patients, where Sanofi/Regeneron’s Dupixent has failed to make an impact. The results reinforce hopes that teze could get a broader label than currently approved monoclonal antibodies, which are largely limited to eosinophilic asthma. In addition, a 70% exacerbation reduction with teze in high-eosinophil patients should allow the Amgen/Astra drug to compete in this population, Jefferies analysts reckon. Teze’s safety has been closely watched since a case of Guillain-Barré syndrome in phase II; all the AAAAI abstract says is that safety findings were similar between teze and placebo. Still, commercial prospects took a hit with the failure of the Source trial, which aimed to show that teze could allow tapering of oral corticosteroids. Notably, Dupixent has been shown to reduce oral steroid use. EvaluatePharma sellside consensus puts teze’s sales at $766m in 2026.
|Navigating a broad label? Tezepelumab's ph3 data|
|AAER reduction over 52 weeks||P value|
|Eosinophil high (≥300 cells/µl)||70%||<0.001|
|Eosinophil low (<300 cells/µl)||41%||<0.001|
|Eosinophil very low (<150 cells/µl)||39%|| Not part of statistical
|AAER=annualised asthma exacerbation rate. *Primary endpoint. Source: AAAAI late-breaking abstract.|