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11.08.2025 07:14:40
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Press Release: Novartis announces both ianalumab -2-
References
1. Novartis data on files
2. Bowman S et al, Safety and efficacy of subcutaneous ianalumab (VAY736) in
patients with primary Sjogren's syndrome: a randomized, double-blind,
placebo-controlled, phase 2b dose-finding trial, Lancet 2022; 399:161-71
3. Dorner T et al, Safety and Efficacy of ianalumab in patients with
Sjogren's disease:52-week results from a randomized, placebo-controlled,
phase 2b dose-ranging study, Arhtritis and Rheumatology 2025,
77(5):560-570
4. Negrini S et al, Sjogren's syndrome: a systemic autoimmune disease, Clin
Exp Med. 2022; 22(1): 9--25
5. Mariette, Primary Sjogren's symptoms, New England Journal of Medecine,
2018, 378;10
6. VAY736, Department of health and human Services, Fast Track Designation,
US Food and Drug Administration, 2025
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2025]
8. ClinicalTrials.gov NCT0539214
https://clinicaltrials.gov/study/NCT05349214 [Last accessed: August 2025]
9. ClinicalTrials.gov NCT05653219
https://clinicaltrials.gov/study/NCT05653219?intr=ianalumab&aggFilters=phase:3&rank=9
[Last accessed: August 2025]
10. ClinicalTrials.gov NCT05639114
https://www.clinicaltrials.gov/study/NCT05639114 [Last accessed: August
2025]
11. ClinicalTrials.gov NCT05126277
https://clinicaltrials.gov/study/NCT05126277 [Last accessed: August
2025]
12. ClinicalTrials.gov NCT05648968
https://clinicaltrials.gov/study/NCT05648968 [Last accessed: August
2025]
13. ClinialTrials.gov NTC06470048
https://clinicaltrials.gov/study/NCT06470048 [Last accessed: August
2025]
14. Phase 2 safety and efficacy of subcutaneous (s.c.) dose ianalumab
(VAY736; Anti-BAFFR mAB) administered monthly over 28 weeks in patients
with Systemic Lupus Erythematosus (SLE) of moderate-to-severe activity,
ACR congress, available at : Phase 2 Safety and Efficacy of Subcutaneous
(s.c.) Dose Ianalumab (VAY736; Anti-BAFFR mAb) Administered Monthly over
28 Weeks in Patients with Systemic Lupus Erythematosus (SLE) of
Moderate-to-Severe Activity - ACR Meeting Abstracts
https://acrabstracts.org/abstract/phase-2-safety-and-efficacy-of-subcutaneous-s-c-dose-ianalumab-vay736-anti-baffr-mab-administered-monthly-over-28-weeks-in-patients-with-systemic-lupus-erythematosus-sle-of-moderate-to-severe/
[Last accessed: August 2025]
15. A Phase 2 Study of ianalumab in patients with primary immune
thrombocytopenia previously treater with at least two lines of therapy,
EHA congress, available at: EHA Library - The official digital education
library of European Hematology Association (EHA)
https://library.ehaweb.org/eha/2025/eha2025-congress/4159389/charlotte.bradbury.a.phase.2.study.of.ianalumab.in.patients.with.primary.html?f=
[Last accessed: August 2025]
16. Novartis to strengthen oncology pipeline with agreement to acquire
Morphosys [AG Press release]. [Press release]. Available at: Novartis to
strengthen oncology pipeline with agreement to acquire MorphoSys AG for
EUR 68 per share or an aggregate of EUR 2.7bn in cash | Novartis
https://www.novartis.com/news/media-releases/novartis-strengthen-oncology-pipeline-agreement-acquire-morphosys-ag-eur-68-share-or-aggregate-eur-27bn-cash
[Last accessed: August 2025]
17. ClinicalTrials.gov NCT05985915
https://clinicaltrials.gov/study/NCT05985915 [Last accessed: August
2025]
18. Maleki Fischbach- M, et al, Manifestations and management of Sjogren's
disease, Arthritis Res Ther. 2024;26(1):43
19. Kerry Gairy et al, Burden of illness among subgroups of px with primary
SjD and systemic involvement, Rheumatology 2021, Volume 60, Issue 4,
April 2021, Pages 1871--1881
20. Conrad N, et al, Incidence, prevalence, and co-occurrence of autoimmune
disorders over time and by age, sex, and socioeconomic status: a
population-based cohort study of 22 millions individuals in the UK,
Lancet. 2023;401(10391):1878-1890;
21. Narváez J et al, Prevalence of Sjogren's syndrome in the general
adult population in Spain: estimating the proportion of undiagnosed cases,
Sci Rep. 2020;10(1):10627
Novartis Media Relations
E-mail: media.relations@novartis.com
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relations line: +41 61 324 7944 E-mail:
investor.relations@novartis.com
(END) Dow Jones Newswires
August 11, 2025 01:15 ET (05:15 GMT)
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