Novartis’ Fabhalta Shows Promise in Slowing Rare Kidney Disease

Novartis has announced strong results for its drug Fabhalta (iptacopan). The treatment slowed the progression of IgA nephropathy, a rare and serious kidney disease, in a major clinical trial.

In the Phase III study, patients taking Fabhalta had a much slower loss of kidney function compared to those on placebo. The drug improved the eGFR slope, a key measure of kidney performance over time. These results confirm Fabhalta met its main goal — protecting kidney health for longer.

The company plans to seek full U.S. regulatory approval in 2026. Fabhalta already holds accelerated approval in the United States for reducing protein levels in the urine of IgA nephropathy patients.

This condition, also called Berger’s disease, happens when immune proteins damage the kidneys’ filtering units. Over time, it can lead to chronic kidney disease or kidney failure. Because treatment options are limited, these results offer new hope for patients worldwide.

Novartis said Fabhalta’s success shows its growing focus on rare diseases. If approved, the drug could become one of the first oral therapies to slow kidney decline and improve long-term outcomes for thousands of patients.