AstraZeneca, Amgen's Tezspire succeeds in

AstraZeneca and Amgen announced on Thursday that their drug Tezspire met all primary and secondary objectives in a Phase 3 trial for eosinophilic esophagitis (EoE). The companies stated the treatment led to statistically significant and clinically meaningful improvements in disease markers, symptoms, and severity, with effects seen at 24 weeks and sustained over one year.

Tezspire is a monoclonal antibody that blocks the protein TSLP, a key driver in certain inflammatory diseases. It is already approved for severe asthma and chronic rhinosinusitis. The drug has become a major commercial product for both partners, with each company reporting over $1 billion in sales last year. AstraZeneca recorded $390 million in Tezspire sales in the second quarter of this year alone, a 45% increase from the same period in 2023.

Potential for a blockbuster expansion

The companies plan to share the detailed results with regulators and present them at a future medical meeting. An approval in EoE would mark a third major indication for the drug. Eosinophilic esophagitis is a chronic inflammatory disease where white blood cells called eosinophils build up in the esophagus, causing swallowing difficulties. According to AstraZeneca, approximately half of patients do not respond to initial therapies like proton pump inhibitors or topical corticosteroids.

Analyst Matt Phipps of William Blair noted in a client note that over 470,000 people in the U.S. are affected by EoE, and the disease's prevalence is rising. He wrote that these factors support an attractive new indication with blockbuster potential for Tezspire.

Competitive landscape and strategic importance

If approved for EoE, Tezspire would compete directly with Sanofi and Regeneron's Dupixent, another anti-inflammatory drug approved for the condition. Regeneron and Sanofi have also described their EoE business as a meaningful growth driver.

The success is strategically important for both companies. For AstraZeneca, it supports the company's ambitious goal of reaching $80 billion in annual revenue by 2030. For Amgen, Tezspire is a key growth product alongside medicines like Uplizna, Imdelltra, and Repatha, helping to sustain momentum ahead of pivotal data readouts for its obesity drug candidates next year.

The partners did not release specific numerical data from the trial. Full results are awaited.