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12.08.2025 07:14:45
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Press Release: Novartis ianalumab Phase III trial -2-
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References
1. Novartis. Data on file.
2. Clinicaltrials.gov. NCT05653219. A Study of Efficacy and Safety of
Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune
Thrombocytopenia Patients Who Failed Steroids (VAYHIT2). Accessed July
21, 2025. https://clinicaltrials.gov/study/NCT05653219
3. Clinicaltrials.gov. NCT05653349. Study of Ianalumab Versus Placebo in
Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia
(ITP) (VAYHIT1). Accessed July 21, 2025.
https://clinicaltrials.gov/study/NCT05653349
4. Clinicaltrials.gov. NCT05648968. A Study of Efficacy and Safety of
Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic
Anemia (VAYHIA) Accessed July 21, 2025.
https://clinicaltrials.gov/study/NCT05648968
5. Rodeghiero F, Stasi R, Gernsheimer T, et al. Standardization of
terminology, definitions and outcome criteria in immune thrombocytopenic
purpura of adults and children: report from an international working
group. Blood. 2009;113(11):2386-2393. doi:10.1182/blood-2008-07-162503
6. Kuter DJ, Mathias SD, Rummel M, et al. Health-related quality of life in
nonsplenectomized immune thrombocytopenia patients receiving romiplostim
or medical standard of care. Am J Hematol. 2012;87:558-61
7. Kuter DJ. The treatment of immune thrombocytopenia (ITP)--focus on
thrombopoietin receptor agonists. Ann Blood. 2021;6:27.
doi:10.21037/aob-2021-itp-04
8. Mingot-Castellano ME, Bastida JM, Caballero-Navarro G, et al. Novel
therapies to address unmet needs in ITP. Pharmaceuticals (Basel).
2022;15(7):779. doi:10.3390/ph15070779
9. US Food and Drug Administration. Orphan drug designation:
ianalumab--treatment of primary immune thrombocytopenia. Published
February 13, 2025. Accessed August 9, 2025.
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1018924
10. European Commission. Community register of orphan medicinal products:
ianalumab. Updated June 30, 2025. Accessed August 9, 2025.
https://ec.europa.eu/health/documents/community-register/html/o3036.htm
11. Dörner T, Bowman SJ, Fox R, et al. Safety and Efficacy of Ianalumab
in Patients With Sjögren's Disease: 52-Week Results From a
Randomized, Placebo-Controlled, Phase 2b Dose-Ranging Study. Arthritis
Rheumatol. 2025;77(5):560-570. doi:10.1002/art.43059
12. Clinicaltrials.gov. NCT05350072. Two-arm Study to Assess Efficacy and
Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
(NEPTUNUS-1). Accessed August 9, 2025.
https://clinicaltrials.gov/study/NCT05350072
13. Clinicaltrials.gov. NCT05349214. Three-arm Study to Assess Efficacy and
Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome
(NEPTUNUS-2). Accessed August 9, 2025.
https://clinicaltrials.gov/study/NCT05349214
14. Clinicaltrials.gov. NCT05639114. Phase 3 Study to Evaluate Two Regimens
of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic
Lupus Erythematosus (SIRIUS-SLE 1) (SIRIUS-SLE 1). Accessed August 9,
2025. https://www.clinicaltrials.gov/study/NCT05639114
15. Clinicaltrials.gov. NCT05126277. Safety, Efficacy and Tolerability of
Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants
With Active Lupus Nephritis (SIRIUS-LN). Accessed August 9, 2025.
https://clinicaltrials.gov/study/NCT05126277
16. Clinicaltrials.gov. NCT06470048. A Clinical Study to Evaluate Ianalumab
in Participants With Diffuse Cutaneous Systemic Sclerosis. Accessed
August 9, 2025. https://clinicaltrials.gov/study/NCT06470048
17. Bowman SJ, Fox R, Dörner T, et al. Safety and efficacy of
subcutaneous ianalumab (VAY736) in patients with primary Sjögren's
syndrome: a randomised, double-blind, placebo-controlled, phase 2b
dose-finding trial. Lancet. 2022;399(10320):161-171.
doi:10.1016/S0140-6736(21)02251-0
18. Shen N, Ignatenko S, Gordienko A, et al. 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 [abstract]. Arthritis Rheumatol. 2023; 75
(suppl 9). Accessed August 9, 2025.
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/
19. Bradbury C, Elverdi T, Trautmann K, et al. A phase 2 study of ianalumab
in patients with primary immune thrombocytopenia previously treated with
at least two lines of therapy (VAYHIT3). HemaSphere.
2025;9(Suppl 1):Abstract S238. Presented at European Hematology
Association (EHA) Congress, June 12--15, 2025. Milan, Italy. Accessed
August 9, 2025.
https://library.ehaweb.org/eha/2025/eha2025-congress/4159389/charlotte.bradbury.a.phase.2.study.of.ianalumab.in.patients.with.primary.html
20. Novartis. Press release. 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. February 5, 2024. Accessed August 9, 2025.
https://www.novartis.com/news/media-releases/novartis-strengthen-oncology-pipeline-agreement-acquire-morphosys-ag-eur-68-share-or-aggregate-eur-27bn-cash
21. Provan D, Newland AC. Current management of primary immune
thrombocytopenia. Adv Ther. 2015;32(10):875-887.
doi:10.1007/s12325-015-0240-z
22. Cooper N, Kruse A, Kruse C, et al. Immune thrombocytopenia (ITP) World
Impact Survey (I-WISh): impact of ITP on health-related quality of life.
Am J Hematol. 2021;96(2):199-207. doi:10.1002/ajh.26083
# # #
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(END) Dow Jones Newswires
August 12, 2025 01:15 ET (05:15 GMT)
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