Press Release: Novartis Vanrafia(R) Phase III -2-

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References

1. Novartis. Data on file.

2. Novartis Pharmaceuticals Corporation. Novartis receives FDA accelerated

approval for Vanrafia(R) (atrasentan), the first and only selective

endothelin A receptor antagonist for proteinuria reduction in primary IgA

nephropathy (IgAN). Available at:

https://www.novartis.com/news/media-releases/novartis-receives-fda-accelerated-approval-vanrafia-atrasentan-first-and-only-selective-endothelin-receptor-antagonist-proteinuria-reduction-primary-iga-nephropathy-igan.

Accessed February 2026.

3. ClinicalTrials.gov. NCT04573478. A Phase 3, Randomized, Double-blind,

Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy

at Risk of Progressive Loss of Renal Function. Available at

https://clinicaltrials.gov/study/NCT04573478. Accessed February 2026.

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

nephropathy. Semin Nephrol. 2025;44:151573.

5. 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.

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 February 2026.

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. Barratt J, Kim SG, Inker LA et al. AFFINITY study: 1-year results of

atrasentan in IgAN. J Am Soc Nephrol. 2024;35(Suppl):720. Abstract

FR-P0855.

11. Heerspink HJL, Jardine M, Kohan DE et al. Atrasentan in patients with

IgAN. N Engl J Med. 2025;392:544--54.

12. Heerspink HJL, Jardine M, Kohan DE et al. Study design and baseline

characteristics of ALIGN, a randomized controlled study of atrasentan in

patients with IgAN. Kidney Int Rep. 2024;10:217--26.

13. Kohan DE, Barratt J, Heerspink HJL et al. Targeting the endothelin A

receptor in IgAN. Kidney Int Rep. 2023;8:2198--210.

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(END) Dow Jones Newswires

February 13, 2026 01:15 ET (06:15 GMT)