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

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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

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https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp

Accessed February 2025.

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Glomerulopathy: A Rare Renal Disease. Int J Mol Sci. 2020;21(2):525.

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University of Washington, Seattle; 1993-2024. Available

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2025.

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Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of

Glomerular Diseases. Kidney Int. 2021;100(4S):S1-S276.

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Rare Complement-Driven Renal Disease. Nat Rev Nephrol.

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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 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.

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Pathway Inhibition with Iptacopan for the Treatment of C3 Glomerulopathy

-- Study Design of the APPEAR-C3G Trial. Kidney Int Rep.

2022;7(10):2150-2159. doi:10.1016/j.ekir.2022.07.004

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With C3 Glomerulopathy. (APPEAR-C3G). Available

from: https://clinicaltrials.gov/study/NCT04817618. Accessed February

2025.

10. 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: https://www.novartis.com/news/media-releases/novartis-receives-fda-

approval-fabhalta-iptacopan-offering-superior-hemoglobin-improvement-abse

nce-transfusions-first-oral-monotherapy-adults-pnh. Accessed February

2025.

11. Novartis. 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). Available from: 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) | Novartis

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 February 2025

12. Novartis Data on File.

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

Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

(APPLAUSE-IgAN). Available

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2025.

14. ClinicalTrials.gov. NCT04889430. A Multicenter, Single-Arm, Open Label

Trial to Evaluate Efficacy and Safety of Oral, Twice Daily LNP023 in

Adult aHUS Patients Who Are Naive to Complement Inhibitor Therapy

(APPELHUS). Available

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2025.

15. ClinicalTrials.gov. NCT05755386. A Multicenter, Randomized, Double-Blind,

Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and

Safety of Iptacopan (LNP023) in Idiopathic Immune Complex Mediated

Membranoproliferative Glomerulonephritis (IC-MPGN) (APPARENT). Available

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16. ClinicalTrials.gov. NCT05268289. An Adaptive, Randomized, Double-Blind,

Dose Exploration, Parallel Group, Placebo Controlled, Multicenter Phase 2

Trial to Evaluate the Efficacy, Safety and Tolerability of LNP023 in

Combination with Standard-of-Care with and without Oral Corticosteroids

in Patients with Active Lupus Nephritis Class III-IV, +/- V. Available

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17. 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. doi:10.2215/CJN.04700513

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(END) Dow Jones Newswires

February 28, 2025 07:39 ET (12:39 GMT)