Novartis on Saturday presented results from the Phase III study of atrasentan which is an investigational oral therapy for patients with IgA nephropathy (IgAN).
The results were presented during a late-breaking clinical trials session at the European Renal Association (ERA) Congress. The study also showed atrasentan has a favorable safety profile consistent with previously reported data, the company said in a statement.
According to the company, US FDA submission for atrasentan in IgAN is on track for the first half of 2024.
“For those living with IgAN and their families, the disease can have a significant impact not only physically, but also mentally. When my son Eddie was diagnosed with IgAN 20 years ago, there were no FDA-approved medicines developed to treat IgAN. That was as devastating as the diagnosis itself because we felt completely in the dark about how to manage the condition,” said Bonnie Schneider, Director and Co-Founder, IgAN Foundation. “It’s a disease that affects people differently, and what works for one person may not work for another. We’re pleased to see ongoing research into different treatments and are excited for a future where the community will have options to meet their individual needs.”
The ALIGN study continues in a blinded manner, and therefore only limited interim analysis results can be presented, the drugmaker said.
“Atrasentan has the potential to help transform how IgAN is managed for many people living with this complex illness,” said David Soergel, M.D., Global Head, Cardiovascular, Renal and Metabolism Development Unit, Novartis. “Our multi-product IgAN portfolio aims to address the needs of a broad, heterogenous patient population with different modes of action to target distinct drivers of the disease, with the ultimate goal of improving patient care in this therapeutic area.”
At ERA, Novartis is also presenting new data across its rare disease portfolio, including 6-month data for Fabhalta (iptacopan) in C3 glomerulopathy (C3G) from the Phase III APPEAR-C3G study, long-term 33-month efficacy and safety data for Fabhalta in C3G from the Phase II extension study, additional data for Fabhalta in IgAN from the 9-month interim analysis of the Phase III APPLAUSE-IgAN study, 1-year Phase I/II data for investigational zigakibart in IgAN, and data from real-world studies in C3G and atypical hemolytic uremic syndrome (aHUS)13-16.
