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AstraZeneca's Tezspire Gains EU Approval for CRSwNP: A Game-Changer in Treatment

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6-K
Filed on: 2025-10-22
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AstraZenecaTezspirechronic rhinosinusitisrespiratory medicineimmunology treatments
AstraZeneca's Tezspire Gains EU Approval for CRSwNP: A Game-Changer in Treatment

Key Information from the Financial Report (Form 6-K)

Company: AstraZeneca PLC Date of Report: October 22, 2025 Commission File Number: 001-11960

Major Announcement:

  • Tezspire (tezepelumab) has been approved in the European Union (EU) for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) as an add-on therapy with intranasal corticosteroids for adult patients who have not adequately responded to standard therapy.

Approval Background:

  • The approval followed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and was based on results from the WAYPOINT Phase III trial. This trial demonstrated:
  • Significant reduction in nasal polyp severity.
  • Near-elimination of the need for surgery.
  • Significant reduction in systemic corticosteroid use compared to placebo.

Market Context:

  • CRSwNP is a prevalent condition affecting approximately 320 million people globally. Nearly half of patients in Europe remain uncontrolled despite existing treatments, highlighting a significant unmet medical need.

Efficacy and Safety:

  • Dr. Oliver Pfaar, an investigator in the WAYPOINT trial, noted that Tezspire represents an innovative treatment option, significantly reducing nasal polyp size and symptom severity.
  • The safety profile of Tezspire was consistent with existing data, with common adverse events including COVID-19, nasopharyngitis, and upper respiratory tract infections.

Commercialization and Collaboration:

  • Tezspire is developed by AstraZeneca in collaboration with Amgen. The companies share costs and profits equally, with AstraZeneca leading development.
  • Tezspire is already approved in the US and several other countries for severe asthma, and regulatory applications are pending in additional markets.

Key Quotes:

  • Ruud Dobber, Executive Vice President at AstraZeneca, emphasized the significance of Tezspire’s approval in addressing the needs of CRSwNP patients in Europe.

Summary:

AstraZeneca's recent approval of Tezspire in the EU for CRSwNP represents a critical advancement in treating a condition that affects millions globally, particularly those who do not respond to conventional treatments. The approval is supported by robust clinical trial data and addresses a significant gap in the market, potentially expanding AstraZeneca's reach in the respiratory and immunology sectors.

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