Press Release: Novartis receives third FDA -2-

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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.

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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.

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(END) Dow Jones Newswires

March 20, 2025 19:11 ET (23:11 GMT)