Novartis Announces Positive Results From Phase III Study Of Iptacopan In IgA Nephropathy

(RTTNews) - Novartis (NVS) said that an investigational phase III study of iptacopan demonstrated clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy or IgAN. The company plans to review interim results with the FDA to enable a potential regulatory submission for accelerated approval. The study continues with final readout (24 months) in 2025.

IgAN is a complement-mediated kidney disease, affects mostly young adults, and is a major cause of chronic kidney disease and kidney failure worldwide.

The company noted that the Phase III APPLAUSE-IgAN study met its pre-specified interim analysis primary endpoint, demonstrating superiority of iptacopan compared to placebo in proteinuria reduction.

In the study, the safety profile of iptacopan (200 mg twice daily) was consistent with previously reported data.

The APPLAUSE-IgAN is the third positive Phase III trial for iptacopan and development program is ongoing across five indications. The regulatory review is underway for paroxysmal nocturnal hemoglobinuria (PNH) in the US and EU.

Novartis intends to submit for possible accelerated approval with the FDA in 2024.

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