Fabhalta (Iptacopan) Receives FDA Approval to Slow Disease Progression in Patients With IgAN

Key Takeaways:

• Fabhalta (iptacopan) has been approved by the US Food and Drug Administration (FDA) to slow disease progression in patients with immunoglobulin A nephropathy (IgAN).
• Iptacopan is a factor B inhibitor that targets the alternative complement pathway, a main driver of kidney function decline.
• In the phase 3 APPLAUSE-IgAN trial, iptacopan showed significant improvement in preserving kidney function and slowing disease progression.

On July 17, 2026, Novartis announced that the FDA approved Fabhalta (iptacopan) to slow the decline of kidney function in patients with IgAN.

IgAN is a common autoimmune kidney disease that affects nearly 25 in 1 million people each year. Disease progression creates a significant care burden as 50% of patients experience kidney failure within 10 to 20 years of diagnosis.

Iptacopan is an oral factor B inhibitor designed to target the alternative complement pathway, a large factor of glomerular inflammation and kidney damage.

FDA approval was based on data from the phase 3 APPLAUSE-IgAN trial, in which iptacopan slowed estimated glomerular filtration rate decline by 48%, illustrating significant improvement in preserving kidney function.

In the trial, iptacopan also demonstrated a favorable safety profile. Abdominal pain, dizziness, and nausea were the most common adverse events among patients.

“This milestone underscores the importance of continued innovation for people living with IgAN and our commitment to addressing the underlying drivers of disease,” said Victor Bultó, president of Novartis.

The approval expands treatment options for patients with IgAN and introduces a targeted therapy designed to slow kidney function decline by addressing an underlying driver of disease.

Reference

Novartis Fabhalta® (iptacopan) receives FDA traditional approval as first and only complement inhibitor to significantly slow kidney function decline in primary IgAN. Novartis. Published July 17, 2026. Accessed Jule 21, 2026. https://www.novartis.com/news/media-releases/novartis-fabhalta-iptacopan-receives-fda-traditional-approval-first-and-only-complement-inhibitor-significantly-slow-kidney-function-decline-primary-igan