Company: AZN
Filing Date: 2025-10-20
Form Type: 6-K
Source: 0001654954-25-011951
Chunk: 2

Company: ASTRAZENECA PLC
Filing Date: 2025-10-20
Form: 6-K
Chunk 2
---
 People living with CRSwNP commonly experience airflow obstruction and symptoms including congestion and an impaired sense of smell. 3-7 For many patients, current therapies such as systemic and intranasal corticosteroids and repeated sinus surgeries do not offer lasting relief. 4

The safety profile and tolerability of Tezspire in the WAYPOINT trial was generally consistent with the known profile of the medicine. 1 The most frequently reported adverse events in the trial were COVID-19, nasopharyngitis and upper respiratory tract infection. 1

The Committee for Medicinal Products for Human Use (CHMP) recently adopted a positive opinion for the approval of Tezspire in the EU for treatment of CRSwNP. 8 Regulatory applications are currently under review in the EU, China, Japan and several other countries.

Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan and more than 60 countries across the globe. 9-11

#### Notes
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP (nasal polyps))

CRSwNP is a complex inflammatory disorder, characterised by persistent inflammation of the nasal mucosa accompanied by benign growths, called nasal polyps. 3,4 Nasal polyps can block nasal passages and lead to breathing problems, difficulty in sense of smell, nasal discharge, facial pain, sleep disturbance and other adverse effects on quality of life. 5-7

Epithelial dysfunction and inflammation are important characteristics of chronic rhinosinusitis and impede the ability of the epithelium to act as a physical and immunological barrier against the external environment. 12,13 Thymic stromal lymphopoietin (TSLP) is an epithelial cytokine that has been implicated in shared pathophysiological processes underlying severe asthma and CRSwNP. 12,13

Current treatments for CRSwNP include intranasal and/or systemic corticosteroids, surgery and biologics. 4,7,14-19

Phase III WAYPOINT trial

WAYPOINT was a double-blind, multi-centre, randomised, placebo-controlled, parallel group trial designed to evaluate the efficacy and safety of tezepelumab in adults with uncontrolled CRSwNP. 1,2,20 Participants received tezepelumab or placebo, administered via subcutaneous injection. The trial also included a post-treatment follow-up period of 12-24