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16.10.2025 07:14:45
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Press Release: Novartis Fabhalta(R) (iptacopan) -2-
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. 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.
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
(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).
6. Pitcher D, Braddon F, Hendry B et al. Long-term outcomes in IgAN. Clin J
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.
# # #
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
October 16, 2025 01:15 ET (05:15 GMT)
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