The FDA Grants Accelerated Approval to Vanrafia, New Treatment Option for Adults with IgA Nephropathy

A major step forward has been made for the IgA Nephropathy (IgAN) community. Last week, the FDA granted accelerated approval to Vanrafia (atrasentan), Novartis’ therapy, for adults with primary IgAN at risk of rapid disease progression. This approval brings new hope to those affected by this progressive, rare kidney disease.

As background, the FDA’s accelerated approval program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need. 

IgA Nephropathy (IgAN) is a kidney disease in which Immunoglobulin A (IgA) builds up in the kidney. IgA is a protein in the blood and is also part of the immune system. Excess IgA can cause inflammation in the kidney and over time, this leads to scarring in the kidney tissue. The severity of kidney disease caused by IgAN varies from person to person. As IgAN progresses, it reduces the kidneys’ ability to filter waste from the blood.

Approval was granted based on interim results from Novartis’ Phase 3 ALIGN trial, which demonstrated a 36.1% reduction in proteinuria compared to placebo. Reductions were seen as early as Week 6 and sustained through Week 36. Vanrafia was also shown to have a favorable safety profile, with no new safety signals observed. Ongoing data from the ALIGN study will evaluate whether Vanrafia slows kidney function decline long-term, with final results expected in 2026.

With this latest announcement, there are now four FDA-approved therapies for IgAN — a major shift from just a few years ago:

• FABHALTA (iptacopan) – Approved for C3G and IgAN
• FILSPARI (sparsentan) – Approved for IgAN
• TARPEYO (budesonide) – Approved for IgAN
• VANRAFIA (atrasentan) – Approved for IgAN

These treatment options, each with different mechanisms of action, allow patients and their care teams to take a more personalized approach to managing this disease.

NephCure remains committed to supporting the IgAN community through continued education, research, and advocacy. While this is an exciting moment, we know the work is far from over. Our focus now turns to ensuring timely, affordable, and equitable access to these therapies for all who need them.

If you or a loved one has IgAN, we encourage you to speak with your doctor to determine which treatment may be right for you.

To read Novartis’ full press release about Vanrafia’s FDA approval, click here.

For more information on IgA Nephropathy, click here. To view and read the available resources about IgAN, please visit NephCure.org.