| Developers: | AstraZeneca Russia, Amgen |
| Last Release Date: | 2025/06/10 |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
2025: Treatment of chronic rhinosinusitis
The Ministry of Health of Russia has updated the marketing authorization of the drug tezepelumab from AstraZeneca and Amgen and added a new indication for its use - chronic rhinosinusitis with nasal polyps (polypous rhinosinusitis). Previously, the drug was used only for the treatment of bronchial asthma. AstraZeneca announced this on June 10, 2025.
In March 2025, the results of the WAYPOINT phase III study showed that AstraZeneca and Amgen tezepelumab clinically and statistically significantly reduce the size of nasal polyps, the need for surgical treatment and the use of systemic glucocorticosteroids in patients with polypous rhinosinusitis (PRS) 1,2
SARS is a complex disease characterized by persistent inflammation of the nasal mucosa and benign neoplasms called nasal polypamia4,5. Nasal polyps and concomitant inflammation can block nasal passages and lead to difficulty breathing, impaired smell, nasal discharge, facial pain, sleep disturbance, and other adverse effects in terms of quality of life.6-8 Current therapies include intranasal and/or systemic glucocorticosteroids, biologics, and surgical treatment.13
The average incidence of polypous rhinosinusitis (RPS) in the population is 1.13% (0.8 to 4.3%). Thus, from 1.2 to 5 million Russians over 15 years old may suffer from PRS13. The frequency of symptoms of chronic rhinosinusitis in the world varies from 5.5% to 28%.
Tezepelumab is also approved for the treatment of severe bronchial asthma in the Russian Federation and more than 60 other countries in the world.3 After receiving the positive results of phase III WAYPOINT, documents for registration of the indication for the use of tezepelumab in polypous rhinosinusitis were submitted for consideration by regulatory authorities in different countries.
| Polypous rhinosinusitis is a fairly common disease with a multifactorial etiology, the pathogenesis of which is characterized by impaired mucociliary activity, insufficient barrier function and chronic inflammation of the mucous membrane of the nasal cavity and paranasal sinuses, its remodeling and formation of polyps. Unfortunately, existing treatments - long-term use of intranasal glucocorticosteroids, surgical interventions - do not in all cases provide proper control of the disease, which extremely negatively affects the quality of life of patients. Certain prospects in the treatment of severe forms of polypous rhinosinusitis, as well as in cases of its combination with bronchial asthma, are associated with the use of genetically engineered biological drugs that contribute to the regression of inflammatory changes in the nasal mucosa and paranasal sinuses, reduce the likelihood of recurrence of the disease and increase the effectiveness of its treatment. said Evgeny Vladimirovich Nosulya, MD, professor, head of the educational department of GBUZ "NIKIO named after L.I. Sverzhevsky" DZM.
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{{quote 'author=noted Anna Braschenkova, medical director of AstraZeneca, Russia and Eurasia, commented. |
It is important for us not only to develop a qualitative and effective drug for the treatment of a particular disease, but also to investigate its therapeutic potential in relation to other nosologies. Tezepelumab of AstraZeneca and Amgen is already used for the treatment of bronchial asthma, but now, after updating the marketing authorization, modern biological therapy opens up new horizons in the treatment of SARS, especially in people with a severe form of the disease. Thanks to this strategy, we have the opportunity to offer effective treatment to more patients suffering from various respiratory diseases, to improve their quality of life,}}
