By Fineline Cube 
Switzerland-based Novartis (NYSE: NVS) announced that it has received accelerated approval from the US Food and Drug Administration (FDA) for Vanrafia (atrasentan). This endothelin A (ETA) receptor antagonist is now approved to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.
Clinical Trial Results
The approval is based on interim results from the Phase III ALIGN study, which demonstrated a significant reduction in proteinuria at 36 weeks compared to placebo. While the study confirmed the drug’s effect on proteinuria, it remains to be established whether Vanrafia slows the decline in kidney function in patients with IgAN.
Acquisition Background
Vanrafia was acquired by Novartis through its USD 3.5 billion acquisition of Chinook Therapeutics, a US-based kidney disease specialist, in 2023. This strategic move underscores Novartis’s commitment to expanding its portfolio in nephrology.-Fineline Info & Tech