Novartis Secures FDA Approval for Vanrafia in IgAN, Intensifying Competition in Rare Kidney Disease Market

Novartis has achieved a significant milestone with the FDA's accelerated approval of Vanrafia (atrasentan) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid progression. This approval not only strengthens Novartis' position in the rare kidney disease market but also triggers a $160 million payout to former Chinook Therapeutics investors.

Vanrafia's Approval and Market Implications

Vanrafia, a selective endothelin A receptor antagonist (ERA), has been approved to reduce elevated protein in the urine in IgAN patients. Notably, the drug's approval comes without the requirement for a Risk Evaluation and Mitigation Strategy (REMS) program, setting it apart from its main competitor, Travere Therapeutics' Filspari.

The absence of a REMS requirement was a crucial factor in the approval, as it was tied to a $2-per-share contingent value right (CVR) payment for Chinook investors following Novartis' $3.2 billion acquisition of the biotech in 2023. This development highlights the strategic importance of Vanrafia's label in Novartis' rare kidney disease portfolio.

Competitive Landscape and Clinical Data

Vanrafia's approval intensifies the competition in the IgAN treatment space, particularly with Travere's Filspari. Both drugs have shown similar efficacy in reducing proteinuria, with Vanrafia demonstrating a 36% relative reduction in urine protein-to-creatinine ratio (UPCR) compared to placebo after 36 weeks of treatment in the phase 3 Align trial. Filspari showed a comparable 35% relative reduction in its Protect trial.

However, key differences exist in their mechanisms and administration. Vanrafia is used in combination with existing treatments, while Filspari offers a dual-action approach as both an ERA and an angiotensin receptor blocker (ARB) in a single drug. Novartis argues that separate dosing allows for greater flexibility in treatment adjustment, though Travere contends this may be more theoretical than practical.

Novartis' Expanding Kidney Disease Portfolio

Vanrafia joins Novartis' growing arsenal of treatments for rare kidney diseases. The company's complement inhibitor, Fabhalta, received FDA approval for IgAN in August 2024 and more recently became the first approved treatment for complement 3 glomerulopathy (C3G). Novartis is also developing zigakibart, an anti-APRIL antibody, for IgAN.

Victor Bulto, Novartis' U.S. president, emphasized the company's strategy of building a comprehensive portfolio for rare kidney diseases. "By constructing the portfolio like this, like a multi-indication, multi-asset, it also creates a compounding capabilities and expertise," Bulto stated, highlighting the potential competitive advantage of Novartis' broad offerings in the nephrology space.