Tezspire (Tezepelumab) Approved by FDA for Chronic Rhinosinusitis with Nasal Polyps, Demonstrating Significant Polyp Reduction and Nasal Congestion Relief

On October 17, AstraZeneca and Amgen jointly announced that the U.S. FDA had approved the supplemental new drug application for Tezspire (tezepelumab subcutaneous injection) for the treatment of adults and pediatric patients aged 12 years and older with inadequately controlled...Chronic Rhinosinusitis with Nasal Polyps(CRSwNP) Additional Maintenance Treatment.

CRSwNP is a complex chronic inflammatory disease characterized by persistent inflammatory responses in the nasal mucosa and benign nasal polyp hyperplasia. Currently, clinical treatments for CRSwNP mainly include intranasal or systemic corticosteroids, nasal polyp surgery, and biologics, but some patients still face issues such as limited treatment efficacy and high recurrence rates, indicating unmet treatment needs.

Tezepelumab is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP). By precisely blocking TSLP, tezepelumab can inhibit the activation of related inflammatory pathways from the source, thereby alleviating disease symptoms. Previously, tezepelumab has been approved for the treatment ofAsthma, isThe World's First Approved TSLP-Targeted Drug。

Clinical data on Tezepelumab for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) primarily come from the Phase III WAYPOINT study. Below are the main clinical data from this study:

• Reduction in Nasal Polyp Size:At week 52, the total Nasal Polyp Score (NPS) in the tezepelumab group decreased by 2.07 points from baseline (95% CI: -2.39 to -1.74), significantly superior to the placebo group (p<0.001). Significant improvement in NPS was observed as early as week 4 of treatment, with sustained efficacy through week 52.

• Relief of Nasal Congestion Symptoms:At week 52, the tezepelumab group showed a 1.03-point decrease (95% CI: -1.20 to -0.86) in Nasal Congestion Score (NCS) from baseline, significantly superior to the placebo group (p<0.001). Significant improvement in NCS was observed as early as week 2 of treatment, with sustained efficacy through week 52.

• Improvement in Olfactory Function:At week 52, the olfactory loss score in the tezepelumab group decreased by 1.00 points from baseline (95% CI: -1.18 to -0.83), significantly better than the placebo group (p<0.001). Significant improvement in olfactory function was observed as early as week 2 of treatment, and the effect persisted up to 52 weeks.

• Improvement in Quality of Life:At week 52, the total score of the 22-Item Sino-Nasal Outcome Test (SNOT-22) in the tezepelumab group decreased by 27.26 points from baseline (95% CI: -32.32 to -22.21), significantly superior to the placebo group (p<0.001). Significant improvement in SNOT-22 scores was observed as early as week 4, and the efficacy persisted through week 52.

• Reducing the Need for Surgery and Hormones:Compared with the placebo group, the need for nasal polyp surgery in the tezepelumab group was reduced by 98% (hazard ratio 0.02, 95% CI: 0.00 to 0.09, p<0.001). The need for systemic glucocorticoid use was reduced by 88% (hazard ratio 0.12, 95% CI: 0.04 to 0.27, p<0.001).

Moreover, the overall incidence of adverse events was similar between the tezepelumab group and the placebo group. The most common adverse events included coronavirus disease 2019 (COVID-19), nasopharyngitis, and upper respiratory tract infections. No clinically meaningful differences were observed in the safety outcome measures between the two groups.

Tezepelumab was first approved in the United States in December 2021 for add-on maintenance treatment in children aged 12 years and older and adults with severe asthma. To date, the drug has been approved for the aforementioned asthma indication in more than 60 countries and regions worldwide, including the United States and the European Union. In the U.S. and EU markets, it is available in two forms for single-use: a pre-filled syringe and an auto-injector, allowing patients to self-administer the injection.

In terms of market performance, Tezepelumab has demonstrated strong growth potential. In 2024,The global sales revenue of the drug reached $1.22 billion, with a year-on-year increase of 87%.。

Currently,Zelilumab, products with the same target are mostly in Phase II or earlier stages., such as QX008N (Quanxin/Joincare, Phase II), Bosakitug (Biotheus/Sino Biopharmaceutical, Phase II), Solrikitug (Merck, Phase II), etc., are expected to be launched in 2-3 years.

Approved for the treatment of allergic rhinitis/chronic rhinosinusitis with nasal polyps (CRSwNP)Other biologics, including omalizumab (Novartis), dupilumab (Sanofi), spesolimab (Connaught Biologics), and mepolizumab (GlaxoSmithKline)etc.

Sina Medicine Comprehensive

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