Novartis’ Atrasentan Approved in China for IgAN Proteinuria Reduction

Novartis' Atrasentan Approved by China NMPA for IgAN Treatment

Switzerland-based Novartis (NYSE: NVS) has received approval from China’s National Medical Products Administration (NMPA) for atrasentan (Vanrafia), a non-immunosuppressive therapy for adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, characterized by a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.

Atrasentan: First Non-Immunosuppressive Therapy for IgAN in China
Atrasentan is the first and currently the only highly selective endothelin A (ETA) receptor antagonist approved in China for IgAN. It has the potential to become a cornerstone of IgA nephropathy treatment.

Phase 3 ALIGN Study Results
In the Phase 3 ALIGN study, patients treated with atrasentan showed a reduction in UPCR as early as week 6. At week 36, there was a 36.1% decrease in 24-hour UPCR compared to the placebo group (P < 0.0001). Atrasentan also demonstrated good safety and tolerability.-Fineline Info & Tech