Company: AZN
Filing Date: 2025-09-22
Form Type: 6-K
Source: 0001654954-25-010967
Chunk: 2

Company: ASTRAZENECA PLC
Filing Date: 2025-09-22
Form: 6-K
Chunk 2
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 sleep. 3-7 This condition affects up to roughly 320 million people worldwide. 7 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. 4,8

The safety profile and tolerability of tezepelumab in the WAYPOINT trial were consistent with the known profile of the medicine. 2

Regulatory applications are currently under review in the US, China, Japan and several other countries based on the WAYPOINT trial. 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. 13

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

Phase III WAYPOINT trial

WAYPOINT is a double-blind, multi-centre, randomised, placebo-controlled, parallel group trial designed to evaluate the efficacy and safety of tezepelumab in adults with severe CRSwNP. 1,2,20 Participants received tezepelumab or placebo, administered via subcutaneous injection. 1,2,20 The trial also included a post-treatment follow-up period of 12-24 weeks for participants who completed the 52-week treatment period. 2 ,20

The co-primary endpoints of the trial, were change from baseline in total nasal polyp size, measured by the endoscopic total Nasal