Data prompts Novartis hope for accelerated atrasentan approval in IgAN

Swiss pharma giant Novartis (NOVN: VX) has announced positive top-line results from the interim analysis of the ongoing pivotal Phase III ALIGN study of atrasentan, an oral endothelin A receptor antagonist (ERA), in patients with IgA nephropathy (IgAN).

The study met its primary efficacy endpoint at the 36-week interim analysis, with atrasentan demonstrating superiority versus placebo with a clinically-meaningful and highly statistically-significant reduction in proteinuria in patients with IgAN receiving supportive care.

"Our development portfolio of three highly differentiated late-stage therapies in IgAN has the potential to provide much-needed treatment options"In the study, the safety profile of atrasentan was consistent with previously reported data from the Phase II AFFINITY study IgAN cohort.