Press Release: Novartis receives positive CHMP -2-

Novartis

122.34 EUR 0.02%

• Charts
• News
• Analysen

Kaufen Verkaufen

References

1. European Medicines Agency. Search results for "polymyalgia rheumatica."

European Medicines Agency.

https://www.ema.europa.eu/en/search?search_api_fulltext=polymyalgia%20rheumatica.

Accessed September 11, 2026.

2. Stone JH, Buttgereit F, Saraux A, et al. Secukinumab in polymyalgia

rheumatica. New England Journal of Medicine. 2026.

doi:10.1056/NEJMoa2602567.

https://www.nejm.org/doi/full/10.1056/NEJMoa2602567.

3. Espígol-Frigolé G, Dejaco C, Mackie SL, Salvarani C, Matteson

EL, Cid MC. Polymyalgia rheumatica. The Lancet.

2023;402(10411):1459--1472. doi:10.1016/S0140-6736(23)01310-7.

https://doi.org/10.1016/S0140-6736(23)01310-7.

4. Gabriel SE, Sunku J, Salvarani C, O'Fallon WM, Hunder GG. Adverse

outcomes of antiinflammatory therapy among patients with polymyalgia

rheumatica. Arthritis & Rheumatism. 1997;40(10):1873-1878.

5. Floris A, Piga M, Chessa E, et al. Long-term glucocorticoid treatment and

high relapse rate remain unresolved issues in the real-life management of

polymyalgia rheumatica: a systematic literature review and meta-analysis.

Clinical Rheumatology. 2022;41(1):19-31. DOI: 10.1007/s10067-021-05819-z.

6. Regeneron Pharmaceuticals, Inc.; Sanofi. Kevzara(R) (sarilumab) injection,

for subcutaneous use: US prescribing information. Revised June 2024.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761037s013lbl.pdf.

Accessed September 11, 2026.

7. European Medicines Agency. Kevzara: EPAR product information [April 25,

2022].

https://www.ema.europa.eu/en/documents/product-information/kevzara-epar-product-information_en.pdf.

Accessed September 11, 2026.

8. European Medicines Agency (EMA). Cosentyx, INN-secukinumab: CHMP

post-authorisation summary of positive opinion. European Medicines

Agency; 2026. Available at:

https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cosentyx-vr-0000326984_en.pdf.

Accessed September 18, 2026.

9. Dejaco C, et al. Secukinumab in polymyalgia rheumatica: Results of the

phase 3 REPLENISH trial. Oral Presentation #OP0116. Presented at:

European Congress of Rheumatology (EULAR) 2026; June 3-6, 2026; London,

UK.

10. Novartis Europharm Limited. Cosentyx(R) (secukinumab): Summary of Product

Characteristics. Available at: Cosentyx, INN-secukinumab:

https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf

[Last accessed: May 2026].

11. Girolomoni G, Mrowietz U, Paul C. Psoriasis: rationale for targeting

interleukin-17. British Journal of Dermatology. 2012;167(4):717-724.

doi:10.1111/j.1365-2133.2012.11099.x.

12. Novartis Cosentyx shows clinically meaningful symptom improvements in

patients with hidradenitis suppurativa. [Press release]. Available

at: https://www.novartis.com/news/media-releases/novartis-cosentyx-shows-

clinically-meaningful-symptom-improvements-patients-hidradenitis-suppurat

iva-pivotal-phase-iii-trials [Last accessed: May 2026].

13. Novartis Cosentyx receives FDA approval for treatment of children and

adolescents with moderate to severe plaque psoriasis [Press release].

Available

at: https://www.novartis.com/news/media-releases/novartis-cosentyx-recei

ves-fda-approval-treatment-children-and-adolescents-moderate-severe-plaqu

e-psoriasis [Last accessed: May 2026].

14. Novartis Cosentyx receives FDA approval for the treatment of children and

adolescents with enthesitis-related arthritis and psoriatic arthritis.

[Press release]. Available

at: https://www.novartis.com/news/media-releases/novartis-cosentyx-receiv

es-fda-approval-treatment-children-and-adolescents-enthesitis-related-art

hritis-and-psoriatic-arthritis [Last accessed: May 2026].

15. Novartis Cosentyx receives positive CHMP opinion for expanded use in

childhood arthritic conditions. [Press release]. Available

at: https://www.novartis.com/news/media-releases/novartis-cosentyx-secuki

numab-receives-positive-chmp-opinion-expanded-use-childhood-arthritic-con

ditions [Last accessed: May 2026].

16. Novartis Cosentyx(R) receives FDA approval for pediatric patients aged

12+ with moderate to severe hidradenitis suppurativa. [Press release].

Available

at:https://www.novartis.com/news/media-releases/novartis-cosentyx-receive

s-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-su

ppurativa [Last accessed: May 2026].

17. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

18. ClinicalTrials.gov. Phase III Study of Efficacy and Safety of Secukinumab

Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in

Patients With Polymyalgia Rheumatica (PMR) (REPLENISH). Identifier

NCT05767034 [June 22, 2026].

https://clinicaltrials.gov/study/NCT05767034. Accessed September 11, 2026

19. Mazzantini M, Torre C, Miccoli M, Baggiani A, Talarico R, Bombardieri S,

Di Munno O. Adverse Events During Longterm Low-dose Glucocorticoid

Treatment of Polymyalgia Rheumatica: A Retrospective Study. Journal of

Rheumatology. 2012;39(3):552-557. doi:10.3899/jrheum.110851.

20. Hutchings A, Hollywood J, Lamping DL, Pease CT, Chakravarty K, Silverman

B, Choy EHS, Scott DGI, Hazleman BL, Bourke B, Gendi N, Dasgupta B.

Clinical Outcomes, Quality of Life, and Diagnostic Uncertainty in the

First Year of Polymyalgia Rheumatica. Arthritis & Rheumatism.

2007;57(5):803-809.

21. Mackie SL, Arun P, Padmanabhan V, Arjona A, Kullman JA. Patient

perspectives on life impact and unmet needs in giant cell arteritis and

polymyalgia rheumatica: insights from social media. Rheumatol Adv Pract.

2026;10(1):rkaf140. doi:10.1093/rap/rkaf140.

# # #

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

(END) Dow Jones Newswires

September 18, 2026 10:51 ET (14:51 GMT)