Novartis has received full approval from the U.S. Food and Drug Administration (FDA ) for Fabhalta to treat adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The decision converts the drug’s accelerated approval into a traditional approval. Fabhalta is now approved to slow kidney function decline in adult IgAN patients at risk for disease progression.
Fabhalta, a first-in-class factor B complement inhibitor, initially received accelerated approval for IgAN two years ago based on its ability to reduce proteinuria, or excess protein in the urine. The latest approval is supported by data showing improvement in kidney function outcomes.
The FDA’s decision was backed by results from a phase 3 placebo-controlled trial that demonstrated statistically significant and clinically meaningful improvement in estimated glomerular filtration rate (eGFR) over two years of treatment. eGFR is a measure used to assess kidney function and track disease progression in patients with IgAN.
The earlier accelerated approval was based on data from the same study that evaluated reductions in proteinuria after nine months compared with placebo. At the time of that readout, Novartis described proteinuria reduction as an increasingly recognized surrogate marker associated with progression to kidney failure.
Commenting on the approval, Victor Bultó, president of Novartis US, said: “Today’s approval reinforces Fabhalta’s role in preserving kidney function by significantly slowing disease progression, an outcome that matters deeply to patients at risk of long-term kidney damage.”
IgAN is an autoimmune kidney disease diagnosed in approximately 25 people per million worldwide. According to Novartis, up to 50% of patients with IgAN and proteinuria progress to kidney failure within 10 to 20 years of diagnosis, often requiring dialysis or kidney transplantation.
Dana Rizk, M.D., of the Division of Nephrology at the University of Alabama at Birmingham, said that significantly slowing kidney function decline is a critical treatment goal. She also said the approval reinforces the importance of targeting underlying disease mechanisms, including complement activation, when treating IgAN to help preserve kidney health.
Fabhalta is one of several Novartis therapies being developed or marketed for IgAN. In 2024, the company obtained accelerated FDA approval for Vanrafia, an oral endothelin A receptor antagonist acquired through Novartis’ $3.2 billion purchase of Chinook Therapeutics in 2023. Earlier this year, Novartis said it would seek full approval for Vanrafia even though the drug did not achieve its kidney function improvement goal in a phase 3 study.
Novartis is also evaluating zigakibart, an anti-APRIL antibody, in a phase 3 IgAN trial. The company amended the study protocol to focus on eGFR with the aim of supporting a potential full approval. An interim eGFR readout is expected in the first half of next year.
Other approved IgAN treatments include Filspari from Travere Therapeutics, which received full approval in 2024, and Tarpeyo from Calliditas Therapeutics, which became the first drug approved in the United States for the condition in 2023. In 2024, Asahi Kasei acquired Calliditas for $1.1 billion.
Fabhalta generated sales of $505 million last year, an increase of 291%. In the first quarter of this year, Novartis reported Fabhalta sales of $169 million, while Vanrafia contributed $16 million. Fabhalta was first approved in 2023 for paroxysmal nocturnal hemoglobinuria and later received FDA approval for C3 glomerulopathy.
The U.S. Food and Drug Administration has granted full approval to Fabhalta for the treatment of adults with IgA nephropathy (IgAN) who are at risk of disease progression. The decision represents an important regulatory milestone for Fabhalta and expands its role in treating a serious kidney condition that can gradually impair renal function.
Why the Fabhalta Approval Matters
The full approval strengthens the clinical position of Fabhalta in the kidney disease treatment landscape. IgA nephropathy can cause progressive kidney damage, and patients with significant disease risk may eventually develop kidney failure. The availability of Fabhalta provides another therapeutic option for eligible patients.
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