Press Release: New Novartis Fabhalta(R) -2-

15.04.24 19:59 Uhr

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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.

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1. Perkovic V, Kollins D, Renfurm R, et al. Efficacy and Safety of Iptacopan

in Patients with IgA Nephropathy: Interim Results from the Phase 3

APPLAUSE-IgAN Study. Presented at the World Congress of Nephrology (WCN);

April 15, 2024; Buenos Aires, Argentina.

2. 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

3. Rizk DV, Maillard N, Julian BA, et al. The Emerging Role of Complement

Proteins as a Target for Therapy of IgA Nephropathy. Front Immunol.

2019;10:504. doi:10.3389/fimmu.2019.00504

4. Medjeral-Thomas NR, O'Shaughnessy MM. Complement in IgA Nephropathy: The

Role of Complement in the Pathogenesis, Diagnosis, and Future Management

of IgA Nephropathy. Adv Chronic Kidney Dis. 2020;27(2):111-119.


5. 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. doi:10.1038/ki.2011.501

6. Reich HN, Troyanov SAA, Scholey JW, Cattran DC. Remission of Proteinuria

Improves Prognosis in IgA Nephropathy. J Am Soc Nephrol.

2007;18(12):3177-3183. doi:10.1681/ASN.2007050526

7. Thompson A, Carroll K, Inker LA, et al. Proteinuria Reduction as a

Surrogate End Point in Trials of IgA Nephropathy. Clin J Am Soc Nephrol.

2019;14(3):469-481. doi:10.2215/CJN.08600718

8. Zhang H, Rizk DV, Perkovic V, et al. Results of a Randomized Double-Blind

Placebo-Controlled Phase 2 Study Propose Iptacopan as an Alternative

Complement Pathway Inhibitor for IgA Nephropathy. Kidney Int.

2024;105(1):189-199. doi:10.1016/j.kint.2023.09.027

9. Rizk DV, Rovin BH, Zhang H, et al. Targeting the Alternative Complement

Pathway with Iptacopan to Treat IgA Nephropathy: Design and Rationale of

the APPLAUSE-IgAN Study. Kidney Int Rep. 2023;8(5):968-979.


10. NCT04578834. A Multi-Center, Randomized, Double-Blind,

Placebo-Controlled, Parallel Group, Phase III Study to Evaluate the

Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients.

Available from: Accessed

April 2024.

11. Novartis. Novartis receives FDA approval for Fabhalta(R) (iptacopan),

offering superior hemoglobin improvement in the absence of transfusions

as the first oral monotherapy for adults with PNH. Available from:

Accessed April 2024.

12. Novartis. Novartis Fabhalta(R) (iptacopan) receives positive CHMP opinion

as first oral monotherapy for adult patients with paroxysmal nocturnal

hemoglobinuria (PNH). Available from:

Accessed April 2024.

13. McGrogan A, Franssen CF, de Vries CS. The Incidence of Primary

Glomerulonephritis Worldwide: A Systematic Review of the

Literature. Nephrol Dial Transplant. 2011;26(2):414-430.


14. 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

15. Novartis. Novartis completes acquisition of Chinook Therapeutics.

Available from:

Accessed April 2024.

16. Novartis. Novartis investigational atrasentan Phase III study

demonstrates clinically meaningful and highly statistically significant

proteinuria reduction in patients with IgA nephropathy (IgAN). Available


Accessed April 2024.

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(END) Dow Jones Newswires

April 15, 2024 14:00 ET (18:00 GMT)

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