APPLAUSE-IgAN trial interim analysis highlights Novartis’ potential to differentiate in IgAN space, says GlobalData

25 Apr, 2024 APPLAUSE-IgAN trial interim analysis highlights Novartis' potential to differentiate in IgAN space, says GlobalData

Posted in Pharma

At this year's World Congress of Nephrology, positive results were presented from Novartis's pre-specified interim analysis of the Phase III APPLAUSE-IgAN clinical trial. According to the analysis, the use of Fabhalta (iptacopan) was shown to reduce proteinuria in patients with immunoglobulin A (IgA) nephropathy (IgAN) compared to placebo. The drug potentially fills an unmet need in the IgAN space as it has an alternate mechanism of action to currently marketed therapies, says GlobalData, a leading data and analytics company.

APPLAUSE-IgAN is an ongoing, randomized, double-blind, placebo-controlled, multicenter, Phase III study to assess the safety and efficacy of Fabhalta. The interim analysis results showed that Fabhalta achieved a 38.3% reduction in proteinuria as measured by 24-hour urine protein to creatinine ratio at nine months versus placebo. Additionally, Fabhalta's safety profile was consistent with previously reported data.

Kajal Jaddoo, Senior Pharma Analyst at GlobalData, comments: "According to key opinion leaders (KOLs) interviewed by GlobalData, unmet needs in the kidney disease space include next-generation therapies with alternate mechanisms of action and enhanced clinical profiles. This study could be of high clinical value to nephrologists who are seeking an optimal treatment of choice for IgAN patients."

If approved, Fabhalta will become the first treatment for IgAN that specifically targets the alternative complement pathway. Iptacopan acts as an inhibitor of complement factor B and was approved in December 2023 for the treatment of adults with paroxysmal nocturnal hemoglobinuria.

Jaddoo concludes: "Novartis completed the acquisition of Chinook Therapeutics in August 2023. The deal was valued at up to $3.5 billion and strengthened Novartis's kidney disease portfolio with Chinook's lead drugs astrasentan and zigakibart for IgAN. This acquisition was significant as it will help Novartis to better address the therapeutic needs of IgAN patients."