27.10.2024 01:49:52
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Press Release: Novartis oral Fabhalta(R) -2-
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 more than 250 million people worldwide.
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References
1. 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.
2. FABHALTA prescribing information. East Hanover, NJ: Novartis
Pharmaceuticals Corp; August 2024.
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. 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 September 2024.
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.
6. Kavanagh D, Bomback A, Vivarelli M, et al. Efficacy and Safety of
Iptacopan in Patients with C3 Glomerulopathy: Results from the Phase 3
APPEAR-C3G Trial. Presented at European Renal Association (ERA) Congress;
May 25, 2024; Stockholm, Sweden.
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. ClinicalTrials.gov. Study of Efficacy and Safety of Iptacopan in Patients
With C3 Glomerulopathy. (APPEAR-C3G). Available from:
https://clinicaltrials.gov/study/NCT04817618. Accessed September 2024.
9. Caravaca-Fontán F, Lucientes L, Cavero T, Praga M. Update on C3
Glomerulopathy: A Complement-Mediated Disease. Nephron.
2020;144(6):272-280.
10. 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.
11. 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.
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