The US Food and Drug Administration granted traditional approval to iptacopan (Fabhalta) to slow kidney function decline in adults with primary immunoglobulin A nephropathy at risk of disease progression, according to a press release from Novartis.

Novartis said iptacopan previously received accelerated approval in August 2024 for reducing proteinuria in adults with primary IgA nephropathy. The traditional approval was granted under priority review.

The approval was based on findings from the phase 3 APPLAUSE-IgAN trial, according to the company. Over 2 years, the annualized mean decline in estimated glomerular filtration rate was 3.0 mL/min/1.73 m² per year with iptacopan and 5.7 mL/min/1.73 m² per year with placebo. Novartis also reported that reductions in proteinuria were observed as early as 2 weeks and sustained over the treatment period.

“The ability to significantly slow kidney function decline is a critical treatment goal. This approval of Fabhalta reinforces the importance of targeting underlying disease mechanisms, including complement activation, in treating IgAN to help preserve kidney health,” said Dana Rizk, MD, professor of medicine in the Division of Nephrology at the University of Alabama at Birmingham and a member of the APPLAUSE-IgAN steering committee.

In the press release, Novartis identified abdominal pain, dizziness, and nausea as the most common adverse events with iptacopan among patients with IgA nephropathy. The company also said iptacopan may increase the risk of serious infections caused by encapsulated bacteria. Fabhalta is available only through a Risk Evaluation and Mitigation Strategy program requiring appropriate vaccinations before treatment.

Source: Novartis