Company: AZN
Filing Date: 2025-10-22
Form Type: 6-K
Source: 0001654954-25-012040
Chunk: 2

Company: ASTRAZENECA PLC
Filing Date: 2025-10-22
Form: 6-K
Chunk 2
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7-9

The safety profile and tolerability of Tezspire in the WAYPOINT trial was generally consistent with the known profile of the medicine. The most frequently reported adverse events in the trial were COVID-19, nasopharyngitis and upper respiratory tract infection. 2

Tezspire was recently approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with inadequately controlled CRSwNP, 10 and regulatory applications are currently under review in China, Japan and several other countries. Tezspire is also approved for severe asthma in the US, EU, Japan and more than 60 countries across the globe. 10-12

#### Notes

#### Chronic Rhinosinusitis with Nasal Polyps
CRSwNP is a complex inflammatory disorder, characterised by persistent inflammation of the nasal mucosa accompanied by benign growths, called nasal polyps. 4,5 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. 7-9

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. 4,13-15 Thymic stromal lymphopoietin (TSLP) is an epithelial cytokine that has been implicated in shared pathophysiological processes underlying severe asthma and CRSwNP. 14,15

Current treatments for CRSwNP include intranasal and/or systemic corticosteroids, surgery and biologics. 5,9,16-21

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. 2,3,22 Participants received tezepelumab or placebo, administered via subcutaneous injection. 2,3,22 The trial also included a post-treatment follow-up period of 12-24 weeks for participants who completed the 52-week treatment period. 2,22

The co-primary endpoints of the trial were change from baseline in total nasal polyp size, measured by the endoscopic total Nasal Polyp Score, and change from baseline in bi-weekly mean nasal congestion