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The APPLAUSE-IgAN study met its pre-specified interim analysis primary endpoint, showing the superiority of iptacopan over a placebo in reducing proteinuria. The safety profile of iptacopan, administered at 200 mg twice daily, aligned with previously reported data. The study continues with the final readout expected in 2025.
Iptacopan is a first-in-class oral factor B inhibitor targeting the alternative pathway of the complement system. It aims to address IgAN and other complement-mediated diseases by inhibiting factor B, an essential protease to the alternative complement pathway.
“These positive data from the Phase III APPLAUSE study reinforce the potential of iptacopan to provide clinically meaningful benefit to patients with IgAN, a debilitating disease that affects mostly young adults,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer at Novartis.
Approximately 25 people per million worldwide are newly diagnosed with IgAN each year. Up to 30% of people who have IgAN with persistent higher levels of proteinuria (>=1 g/day) may progress to kidney failure within 10 years. There is a need for effective, targeted therapies for IgAN that slow or prevent progression to kidney failure.
The APPLAUSE-IgAN is the third positive Phase III trial for iptacopan and development program is ongoing across five indications. Iptacopan is currently under review by regulators following positive Phase III results in paroxysmal nocturnal hemoglobinuria (PNH) in the US and EU.
Novartis plans to review the interim results with the FDA and aims to submit for possible accelerated approval in 2024. The company recently expanded its renal portfolio with two additional late-stage medicines in development for IgAN, following the acquisition of Chinook Therapeutics.
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