Company: AZN
Filing Date: 2025-10-22
Form Type: 6-K
Source: 0001654954-25-012040
Chunk: 1

Company: ASTRAZENECA PLC
Filing Date: 2025-10-22
Form: 6-K
Chunk 1
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 Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and was based on positive results from the WAYPOINT Phase III trial, presented at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress and simultaneously published in The New England Journal of Medicine . 1-3 In the trial, Tezspire demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity , and showed near-elimination of the need for surgery and significant reduction in systemic corticosteroid use vs. placebo. 2,3

Dr. Oliver Pfaar, Chair of the Section Rhinology and Allergy, ENT-Department, University Hospital Marburg, Philipps-Universität Marburg in Marburg, Germany and investigator in the WAYPOINT trial, said: "Chronic rhinosinusitis with nasal polyps is challenging to treat, as it often requires repeat surgeries and ongoing treatment with systemic corticosteroids, both of which can result in serious side effects. Tezepelumab's approval in the EU means clinicians have an innovative new treatment option that has shown a clinically meaningful and significant reduction in nasal polyp size, symptom severity and the need for surgery and systemic corticosteroid use compared to placebo."

Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: "In Europe, we know that nearly half of patients with chronic rhinosinusitis with nasal polyps remain uncontrolled despite treatment with standard of care, which is why today's approval of Tezspire is such an important step forward in this challenging disease. This approval broadens Tezspire's benefits beyond severe asthma and reinforces Tezspire's innovative mechanism of action that targets thymic stromal lymphopoietin (TSLP), uniquely addressing epithelial-driven inflammation at its source."

CRSwNP affects approximately 320 million people worldwide and is a complex disease characterised by epithelial-driven inflammation and benign polyp growths within the nasal cavity. 4,5 Nearly half of the patients diagnosed with CRSwNP in Europe remain uncontrolled, and for many patients, current therapies such as systemic corticosteroids and repeated sinus surgeries do not offer lasting relief. 5,6 People living with CRSwNP commonly experience airflow obstruction and symptoms including congestion and an impaired sense of smell. 5,