Amgen and AstraZeneca’s co-developed blockbuster therapy Tezspire (tezepelumab) scored a Phase III win in a third epithelial-driven inflammatory disease – potentially paving the way for the drug to secure a new addition to its label.
In the CROSSING trial (NCT05583227), the big pharma duo set out to determine Tezspire’s therapeutic potential in adult and adolescent patients with symptomatic and uncontrolled versions of an inflammatory oesophageal disease called eosinophilic oesophagitis (EoE).
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As per a topline readout from the study, which is currently evaluating two once-four-weekly doses of Tezspire in EoE, patients who received the drug found it significantly easier to swallow than those in the placebo group at week 24 – meeting one of the trial’s co-primary endpoints. This effect on ease of swallowing was also sustained through to week 52.
On top of its potential to improve a key symptom of EoE, Tezspire allowed significantly more patients to achieve histologic remission, meaning the drug also met its second co-primary endpoint. In this study, Amgen and AstraZeneca classed histologic remission as eosinophil levels of six or fewer per high-power field (HPF) across multiple oesophageal biopsies. According to a systematic review of the histological remission criteria for EoE published in JGH Open, there is significant variation in the thresholds used to define remission, with Amgen and AstraZeneca’s scoring sitting at the more stringent end of the scale.
As per CROSSING’s readout, Tezspire’s safety profile in EoE was similar to its approved indications.
Next steps for Tezspire in EoE
Following the positive outcome of the CROSSING trial, partners Amgen and AstraZeneca will share the results with regulatory authorities. The pair will also present detailed data from the study at an upcoming medical conference.
Amgen’s executive vice president of R&D, AI and data, Jay Bradner, said: “In this Phase III trial, Tezspire improved both the underlying inflammation and the swallowing difficulties that can make EoE so disruptive for patients. That combination is important for patients and builds confidence in Tezspire as a potential new treatment for people struggling with EoE.”
Extending Tezspire’s blockbuster legacy
Tezspire’s efficacy in EoE will be welcome news for partners Amgen and AstraZeneca, as the two seek an expanded role for their blockbuster drug across several epithelial inflammatory disorders – including EoE and chronic obstructive pulmonary disease (COPD), the latter a respiratory condition.
Currently, the US Food and Drug Administration (FDA) has given Tezspire, a thymic stromal lymphopoietin (TSLP) blocker, the regulatory greenlight as an add-on maintenance treatment in both severe asthma and inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) – leading it to reach blockbuster status in 2025 by generating $1.13bn in revenue for AstraZeneca.
The drug’s sales have also been on an upward trajectory this year, with AstraZeneca reporting a 45% revenue uptick to $390m in the second quarter of 2026. Now, with another indication potentially added to the mix, GlobalData analysts forecast peak sales of over $4bn for Tezspire.
However, it is currently unclear how Tezspire, if approved, will fare against competition from currently approved medicines in the EoE arena – including Sanofi and Regeneron’s immunology stalwart, Dupixent (dupilumab) and Takeda’s Eohilia (budesonide oral suspension).
