Novartis Aktie
WKN: 904278 / ISIN: CH0012005267
03.04.2025 02:12:47
|
Press Release: Novartis receives FDA accelerated -2-
guarantee that Vanrafia will be commercially successful in the future. In particular, our expectations regarding Vanrafia could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.
Reimagine medicine with us: Visit us at https://www.novartis.com/ https://www.novartis.com and connect with us on https://www.linkedin.com/company/novartis/ LinkedIn, https://www.facebook.com/novartis/ Facebook, https://twitter.com/Novartis X/Twitter and https://instagram.com/novartis?igshid=MzRlODBiNWFlZA==__;!!N3hqHg43uw!pjp8z253J5NjaOYrW65UbAAlHeHRdQ-w0m4ezZxEQEl0ptafXN2M99VRIk39pf49PAc8NbK93Pxp3uaSBQkAf8oEnzWXG8Sk$ Instagram.
References
1. VANRAFIA prescribing information. East Hanover, NJ: Novartis
Pharmaceuticals Corp; April 2025.
2. Heerspink HJL, Jardine M, Kohan DE, et al. Atrasentan in Patients with
IgA Nephropathy. N Engl J Med. 2025;392(6):544-554.
doi:10.1056/NEJMoa2409415
3. Xie J, Kiryluk K, Wang W, et al. Predicting progression of IgA
nephropathy: new clinical progression risk score. PLoS One.
2012;7(6):e38904. doi:10.1371/journal.pone.0038904
4. Rodrigues JC, Haas M, Reich HN. IgA Nephropathy. Clin J Am Soc Nephrol.
2017;12(4):677-686. doi:10.2215/CJN.07420716
5. Pitcher D, Braddon F, Hendry B, et al. Long-Term Outcomes in IgA
Nephropathy. Clin J Am Soc Nephrol. 2023;18(6):727-738.
doi:10.2215/CJN.0000000000000135
6. Hastings MC, Bursac Z, Julian BA, et al. Life Expectancy for Patients
From the Southeastern United States With IgA Nephropathy. Kidney Int Rep.
2017;3(1):99-104. Published 2017 Aug 24. doi:10.1016/j.ekir.2017.08.008
7. Sim JJ et al. Poster TH-PO615 presented at: ASN Kidney Week 2023;
November 2-5, 2023; Philadelphia, PA.
8. Bobart SA, Alexander MP, Shawwa K, et al. The association of
microhematuria with mesangial hypercellularity, endocapillary
hypercellularity, crescent score and renal outcomes in immunoglobulin A
nephropathy. Nephrol Dial Transplant. 2021;36(5):840-847.
doi:10.1093/ndt/gfz267
9. Saha MK et al. Poster TH-PO1016 presented at: ASN Kidney Week 2019;
November 5-10, 2019; Washington, DC.
10. National Institute of Diabetes and Digestive and Kidney Diseases. IgA
nephropathy. Available from:
https://www.niddk.nih.gov/health-information/kidney-disease/iga-nephropathy.
Accessed March 2025.
11. Kwon CS, Daniele P, Forsythe A, Ngai C. A systematic literature review of
the epidemiology, health-related quality of life impact, and economic
burden of immunoglobulin A nephropathy. J Health Econ Outcomes Res.
2021;8(2):36-45. doi:10.36469/001c.26129
12. Kidney Disease: Improving Global Outcomes (KDIGO) 2021 Clinical Practice
Guideline for the Management of Glomerular Diseases. Kidney Int.
2021;100(4):S1-S276. doi:10.1016/j.kint.2021.05.021
13. Boyd JK, Cheung CK, Molyneux K, Feehally J, Barratt J. An Update on the
Pathogenesis and Treatment of IgA Nephropathy. Kidney Int.
2012;81(9):833-843.
14. ClinicalTrials.gov. NCT04573478. A Phase 3, Randomized, Double-blind,
Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy
at Risk of Progressive Loss of Renal Function. Available from
https://clinicaltrials.gov/study/NCT04573478. Accessed March 2025.
15. FABHALTA prescribing information. East Hanover, NJ: Novartis
Pharmaceuticals Corp; August 2024.
16. ClinicalTrials.gov. A Study of BION-1301 in Adults With IgA Nephropathy.
Identifier NCT05852938. Available at:
https://clinicaltrials.gov/ct2/show/NCT05852938. Accessed March 2025.
# # #
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
April 02, 2025 20:13 ET (00:13 GMT)

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