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21.03.2025 00:10:52
|
Press Release: Novartis receives third FDA -2-
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. FABHALTA prescribing information. East Hanover, NJ: Novartis
Pharmaceuticals Corp; March 2025.
2. Martín B, Smith RJH. In: Adam MP, Feldman J, Mirzaa GM, et al.,
editors. C3 Glomerulopathy. GeneReviews(R) [Internet]. Updated 2018.
University of Washington, Seattle; 1993-2024. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK1425/. Accessed February 2025.
3. Schena FP, Esposito P, Rossini M. A Narrative Review on C3
Glomerulopathy: A Rare Renal Disease. Int J Mol Sci. 2020;21(2):525.
4. Caravaca-Fontán F, Lucientes L, Cavero T, Praga M. Update on C3
Glomerulopathy: A Complement-Mediated Disease. Nephron.
2020;144(6):272-280.
5. Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases
Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of
Glomerular Diseases. Kidney Int. 2021;100(4S):S1-S276.
doi:10.1016/j.kint.2021.05.021
6. National Kidney Foundation. Treatment for C3G. National Kidney
Foundation. Available from:
https://www.kidney.org/kidney-topics/treatment-c3g. Accessed February
2025.
7. Smith RJH, Appel GB, Blom AM, et al. C3 Glomerulopathy -- understanding a
rare complement-driven renal disease. Nat Rev Nephrol.
2019;15(3):129-143.
8. Feldman DL, Bomback A, Nester C. Voice of the patient: report of
externally led patient-focused drug development meeting on Complement 3
Glomerulopathy (C3G). National Kidney Foundation. Published March 26,
2018. Available from:
https://www.kidney.org/sites/default/files/C3G_EL-PFDD_VoP-Report_3-29-18.pdf.
Accessed February 2025.
9. Lafayette R, Sidhu R, Proudfoot C, et al. Quality of life and fatigue
burden in individuals living with Complement 3 Glomerulopathy -- a
real-world study. Nephrol Dial Transplant. 2024;39(Suppl 1).
10. Smith RJ, Kavanagh D, Vivarelli M, et al. Efficacy and safety of
iptacopan in patients with C3 glomerulopathy: 12-Month results from the
Phase 3 APPEAR-C3G study. Presented at American Society of Nephrology
(ASN) Kidney Week 2024; October 23-27, 2024; San Diego, CA.
11. Novartis. Novartis oral Fabhalta(R) (iptacopan) receives positive CHMP
opinion for the treatment of adults living with C3 glomerulopathy (C3G).
Available from:
https://www.novartis.com/news/media-releases/novartis-oral-fabhalta-iptacopan-receives-positive-chmp-opinion-treatment-adults-living-c3-glomerulopathy-c3g.
Accessed March 2025.
12. ClinicalTrials.gov. Study of Efficacy and Safety of Iptacopan in Patients
With C3 Glomerulopathy. (APPEAR-C3G). Available from:
https://clinicaltrials.gov/study/NCT04817618. Accessed February 2025.
13. Ravindran A, Fervenza FC, Smith RJH, Sethi S. C3 Glomerulopathy
Associated with Monoclonal Ig is a Distinct Subtype. Kidney Int.
2018;94(1):178-186.
14. Medjeral-Thomas NR, O'Shaughnessy MM, O'Regan JA, et al. C3
Glomerulopathy: Clinicopathologic Features and Predictors of Outcome.
Clin J Am Soc Nephrol. 2014;9(1):46-53.
# # #
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
March 20, 2025 19:11 ET (23:11 GMT)
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