Novartis Advances IgAN Treatment Landscape with Positive Phase 3 Results for Fabhalta

Novartis has announced significant progress in the treatment of IgA nephropathy (IgAN), a rare kidney disease, with positive final results from its Phase 3 Applause-IgAN trial for Fabhalta. The study demonstrated that the complement factor B inhibitor can effectively slow kidney function decline and disease progression, positioning the drug for full FDA approval and reinforcing Novartis's strong presence in the IgAN market.

Fabhalta's Clinical Success and Regulatory Prospects

The two-year Applause-IgAN trial compared twice-daily doses of Fabhalta with a placebo in IgAN patients. Results showed that patients treated with Fabhalta had significantly better outcomes on a scale measuring kidney filtration of blood waste. This success follows Fabhalta's initial accelerated FDA approval in 2024, which was based on earlier data showing reduced protein levels in patients' urine.

With these final study results, Novartis plans to seek full, traditional FDA approval for Fabhalta in IgAN patients next year. The company will present detailed results at upcoming medical conferences, further solidifying the drug's efficacy profile.

Novartis's Expanding IgAN Portfolio

Fabhalta's success is part of Novartis's broader strategy in the IgAN space. The drug has already secured FDA clearances for paroxysmal nocturnal hemoglobinuria in 2023 and C3 glomerulopathy in 2025. In the first half of 2025, Fabhalta generated $201 million in revenue, marking it as one of Novartis's priority brands.

The Swiss pharmaceutical giant has further strengthened its IgAN pipeline through strategic acquisitions. In 2023, Novartis acquired Chinook Therapeutics for up to $3.5 billion, gaining two experimental IgAN drugs. One of these, Vanrafia, received FDA approval for IgAN in April 2025. Additionally, Novartis is advancing zigakibart, an investigational anti-APRIL antibody, through Phase 3 testing for IgAN.

Competitive Landscape in IgAN Treatment

As Novartis advances its IgAN efforts, the competitive landscape is intensifying. Other pharmaceutical companies are making significant strides in developing IgAN treatments:

• Travere Therapeutics' Filspari is approved to slow kidney function decline in adults with primary IgAN at risk of disease progression.
• Calliditas Therapeutics' Tarpeyo is cleared for treating patients at risk of IgAN progression.
• Otsuka Pharmaceutical has filed for FDA approval of sibeprenlimab and could receive approval within weeks.
• Vera Therapeutics reported a Phase 3 research win in June 2025.

The increasing focus on IgAN has led to substantial investments in the field, with companies like Biogen and Vertex spending billions to acquire firms with IgAN drugs in their pipelines.