Novartis unveiled Phase III findings on atrasentan, an investigational oral therapy targeting patients with IgA nephropathy (IgAN), during the European Renal Association (ERA) Congress. The results, showcased in a late-breaking clinical trials session, highlight atrasentan’s favorable safety profile consistent with previous data, the company stated.
The US FDA submission for atrasentan in IgAN remains on track for the first half of 2024, signaling progress in addressing the unmet medical needs of IgAN patients. Bonnie Schneider, Director and Co-Founder of IgAN Foundation, emphasized the impact of the disease on individuals and families, underscoring the significance of ongoing research in developing treatment options tailored to individual needs.
As reported by Financial Express, Novartis continues the ALIGN study in a blinded manner, limiting interim analysis disclosures. David Soergel, M.D., Global Head of Novartis’ Cardiovascular, Renal, and Metabolism Development Unit, expressed optimism about atrasentan’s potential to transform IgAN management, part of the company’s multi-product IgAN portfolio aimed at addressing diverse patient populations.
At ERA, Novartis also presented updates across its rare disease portfolio, including data on Fabhalta in C3 glomerulopathy (C3G) and IgAN, as well as Phase I/II findings on investigational zigakibart in IgAN, underscoring its commitment to advancing therapies in nephrology.