Novartis (NYSE: NVS), a global healthcare company, has released interim results from an ongoing Phase III study for its endothelin A receptor antagonist (ERA) atrasentan, indicating a significant milestone in the treatment of IgA nephropathy (IgAN), a rare kidney disease. The trial successfully met its primary endpoint, demonstrating a clinically meaningful and highly statistically significant reduction in proteinuria compared to placebo.
Acquisition and Development of Atrasentan
The atrasentan drug was integrated into Novartis’s portfolio through the acquisition of Chinook Therapeutics earlier this year. This strategic move has positioned Novartis to advance the development of atrasentan, with the interim results serving as a strong foundation for further regulatory submissions.
Future Regulatory Plans and Continued Research
Novartis plans to leverage these positive data to support an accelerated approval application for atrasentan in the US market. The company will also continue to investigate other endpoints, including changes in kidney function, safety, and tolerability, with a confirmatory analysis expected in 2026.
Expanding IgAN Treatment Options
In addition to atrasentan, Novartis’s IgAN program includes other promising candidates such as iptacopan and zigakibart, both of which are in the late stages of development. This comprehensive approach underscores Novartis’s commitment to providing innovative treatment options for patients with IgA nephropathy.-Fineline Info & Tech
