Press Release: Novartis receives FDA approval for -2-

Novartis

109.00 EUR 3.32%

• Charts
• News
• Analysen

Kaufen Verkaufen

References

1. Rhapsido(R) (remibrutinib) Prescribing Information. Novartis

Pharmaceuticals Corp.

2. Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in

chronic spontaneous urticaria. A GA(2)LEN task force report. Allergy.

2011;66:317-330. doi:10.1111/j.1398-9995.2010.02496.x

3. The World Bank. Population, total. Accessed June 2025.

https://data.worldbank.org/indicator/SP.POP.TOTL

4. Kolkhir P, Muñoz M, Asero R, et al. Autoimmune chronic spontaneous

urticaria. J Allergy Clin Immunol. 2022;149(6):1819-1831.

doi:10.1016/j.jaci.2022.04.010

5. Kolkhir, P., Giménez-Arnau, A.M., Kulthanan, K. et al. Urticaria.

Nat Rev Dis Primers. 8, 61 (2022).

https://doi.org/10.1038/s41572-022-00389-z

6. Mendes-Bastos P, Brasileiro A, Kolkhir P, et al. Bruton's tyrosine kinase

inhibition-An emerging therapeutic strategy in immune-mediated

dermatological conditions. Allergy. 2022;77(8):2355-2366.

7. Maurer M, Costa C, Gimenez Arnau A, et al. Antihistamine-resistant

chronic spontaneous urticaria remains undertreated: 2-year data from the

AWARE study. Clin Exp Allergy. 2020;50:1166-1175. doi: 10.1111/cea.13716

8. Friedman A, Kwatra SG, Yosipovitch G. A Practical Approach to Diagnosing

and Managing Chronic Spontaneous Urticaria. Dermatol Ther (Heidelb).

2024;14(6):1371-1387. doi: 10.1007/s13555-024-01173-5

9. Mendelson M, Bernstein J, Gabriel S, et al. Patient-reported impact of

chronic urticaria compared with psoriasis in the United States. J

Dermatolog Treat. 2017; 28(3):229-236. doi:10.1080/09546634.2016.1227421

10. Maurer M, Abuzakouk M, Bérard F, et al. The burden of chronic

spontaneous urticaria is substantial: Real-world evidence from

ASSURE-CSU. Allergy. 2017;72(12):2005-2016. doi:10.1111/all.13209

11. Balp M-M, Krupsky K, Balkaran BL, et al. Oral presentation at: European

Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2023;

June 9--11, 2023; Hamburg, Germany.

12. Maurer M, Raap U, Staubach P, et al. Antihistamine-resistant chronic

spontaneous urticaria: 1-year data from the AWARE study. Clin Exp

Allergy.2019; 49: 655--662. https://doi.org/10.1111/cea.13309

13. Metz M, Giménez-Arnau A, Hide M, et al. Long-term efficacy and

safety of remibrutinib in patients with chronic spontaneous urticaria in

the Phase 3 REMIX-1 and REMIX-2 studies. Presented as a late oral

abstract session on clinical trials at EAACI 2024; May 31-June 3, 2024;

Valencia, Spain.

Novartis Media Relations

E-mail: media.relations@novartis.com

Novartis Investor Relations Central investor

relations line: +41 61 324 7944 E-mail:

investor.relations@novartis.com

9/25 UPR FA-11459252

(END) Dow Jones Newswires

September 30, 2025 16:15 ET (20:15 GMT)