Tezspire scores Phase 3 win in eosinophilic esophagitis, challenging Dupixent

Amgen and AstraZeneca reported positive topline Phase 3 results for Tezspire (tezepelumab) in eosinophilic esophagitis (EoE), a chronic inflammatory disorder that can cause painful or difficult swallowing.

In the 368-patient CROSSING trial, Tezspire met both co-primary endpoints at 24 weeks:
histologic remission, reflecting reduced esophageal inflammation, and a meaningful reduction in the frequency and severity of dysphagia.

Improvements were sustained through 52 weeks, and the drug also met key secondary endpoints involving endoscopic and histologic disease measures. The safety profile was generally consistent with Tezspire’s existing approved uses.

The results could support a future EoE label expansion. Tezspire is already approved in several markets for severe asthma and, in some regions, chronic rhinosinusitis with nasal polyps.

The news intensifies competition with Dupixent (dupilumab), marketed by Sanofi and Regeneron and already approved for EoE, as well as Takeda’s Eohilia. However, the companies have released topline rather than detailed comparative data, so Tezspire’s effectiveness versus Dupixent cannot yet be determined.

Amgen and AstraZeneca said they plan to share the full results with regulators and present them at a future medical meeting. Tezspire remains investigational for EoE until regulatory approval.