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Interim analysis of APPLAUSE-IgAN trial sheds positive light on Fabhalta for IgAN

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 by 38.3% in patients with immunoglobulin A (IgA) nephropathy (IgAN) compared to placebo. Key opinion leaders interviewed by GlobalData emphasised that unmet needs in the kidney disease space include next-generation therapies with alternate mechanisms of action and enhanced clinical profiles. If approved, Fabhalta will become the first treatment for IgAN that specifically targets the alternative complement pathway. GlobalData believes that this study could be of high clinical value to nephrologists who are seeking an optimal treatment of choice for IgAN patients.

APPLAUSE-IgAN is an ongoing, randomised, 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.

Iptacopan acts as an inhibitor of complement factor B and was approved in December 2023 for the treatment of adults with paroxysmal nocturnal haemoglobinuria. In March 2024, Fabhalta received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use.

Novartis completed the acquisition of Chinook Therapeutics in August 2023. The deal was valued at up to $3.5bn and strengthened Novartis’s kidney disease portfolio with Chinook’s lead drug astrasentan hydrochloride. This acquisition deal is significant as it will help Novartis to better address the therapeutic needs of kidney disease patients.

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