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


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References

1. Novartis. Data on file.

2. Kwon CS, Daniele P, Forsythe A et al. 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;8:36--45.

3. Cheung C, Barratt J. The rapidly changing treatment landscape of IgA

nephropathy. Semin Nephrol 2025;44:151573.

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4. Novartis Pharmaceuticals Corporation. Fabhalta prescribing information.

2023 (2025 update). Available at:

https://www.novartis.com/us-en/sites/novartis_us/files/fabhalta.pdf

(accessed October 2025).

5. Novartis Pharmaceuticals Corporation. Novartis receives FDA accelerated

approval for Fabhalta(R) (iptacopan), the first and only complement

inhibitor for the reduction of proteinuria in primary IgA nephropathy

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(IgAN) (2024). Available at:

https://www.novartis.com/news/media-releases/novartis-receives-fda-accelerated-approval-fabhalta-iptacopan-first-and-only-complement-inhibitor-reduction-proteinuria-primary-iga-nephropathy-igan

(accessed October 2025).

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Am Soc Nephrol 2023;18:727--8.

7. Mohd R, Mohammad Kazmin NE, Abdul Cader R, et al. Long-term outcome of

immunoglobulin A (IgA) nephropathy: a single center experience. PLoS One.

2021;16:e0249592.

8. National Kidney Foundation. The voice of the patient (2020). Available

at: https://igan.org/wp-content/uploads/2021/01/VOP_IgAN_12-7-20__FNL.pdf

(accessed October 2025).

9. 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:S1--276.

10. Perkovic V, Barratt J, Rovin B, et al. Alternative complement pathway

inhibition with iptacopan in IgA nephropathy. N Engl J Med.

2025;392:531--543.

11. Fabhalta(R). EMA Summary of Product Characteristics. Novartis Europharm

Limited (2024). Available at:

https://www.ema.europa.eu/en/documents/product-information/fabhalta-epar-product-information_en.pdf

(accessed October 2025).

12. PHARMCUBE. Novartis expands indications for iptacopan, capmatinib in

China (2025). Available at: Novartis Expands Indications for Iptacopan,

Capmatinib in China PharmCube-News & Reports

https://www.pharmcube.com/en/news/detail/d48ad6785b1d4cedbed979a8e6a8192f?type=dailyNews

(accessed October 2025).

13. Fineline Cube. Novartis' fabhalta approved in China for C3 glomerulopathy

(2025). Available at: Novartis' Fabhalta Approved in China for C3

Glomerulopathy - Insight, China's Pharmaceutical Industry

https://flcube.com/?p=31174 (accessed October 2025).

14. Pharma Japan. Novartis makes full foray into nephrology space with

fabhalta: exec (2025). Available at: Novartis Makes Full Foray into

Nephrology Space with Fabhalta: Exec | PHARMA JAPAN

https://pj.jiho.jp/article/253231 (accessed October 2025).

15. Novartis. Press release. Novartis receives third FDA approval for oral

Fabhalta(R) (iptacopan) -- the first and only treatment approved in C3

glomerulopathy (C3G) (2025). Available at:

https://www.novartis.com/news/media-releases/novartis-receives-third-fda-approval-oral-fabhalta-iptacopan-first-and-only-treatment-approved-c3-glomerulopathy-c3g

(accessed October 2025).

16. Clinicaltrials.gov. NCT04889430. Efficacy and Safety of Iptacopan

(LNP023) in Adult Patients with Atypical Hemolytic Uremic Syndrome Naive

to Complement Inhibitor Therapy (APPELHUS). Available at:

https://clinicaltrials.gov/study/NCT04889430 (accessed October 2025).

17. Clinicaltrials.gov. NCT05755386. Study of Efficacy and Safety of

Iptacopan in Participants With IC-MPGN (APPARENT). Available at:

https://clinicaltrials.gov/study/NCT05755386 (accessed October 2025).

18. Clinicaltrials.gov. NCT05268289. Study of Efficacy and Safety of LNP023

in Participants With Active Lupus Nephritis Class III-IV, +/ - V.

Available at: https://clinicaltrials.gov/study/NCT05268289 (accessed

October 2025).

19. Rizk DV, Rovin BH, Zhang H et al. Targeting the alternative complement

pathway with iptacopan to treat IgAN: design and rationale of the

APPLAUSE-IgAN study. Kidney Int Rep 2023;8:968--79.

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Novartis Media Relations

E-mail: media.relations@novartis.com

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E-mail: investor.relations@novartis.com

(END) Dow Jones Newswires

October 16, 2025 01:15 ET (05:15 GMT)

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