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# Novartis Seeks Accelerated OK for Nephropathy Drug
- URL: https://www.fdaweb.com/novartis-seeks-accelerated-ok-for-nephropathy-drug/
- Published: 2023-10-02T12:00:00.000Z
- Updated: 2026-09-14T18:59:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155462

Novartis says it will seek accelerated approval next year for its IgA nephropathy (IgAN) drug iptacopan after announcing “positive top-line results” from a planned interim analysis of the Phase 3 APPLAUSE-IgAN study (NCT04578834) at nine months. “Iptacopan, an investigational factor B inhibitor targeting the alternative complement pathway, demonstrated superiority versus placebo in proteinuria (protein in urine) reduction and provided a clinically meaningful and highly statistically significant proteinuria reduction on top of supportive care in patients with IgA nephropathy (IgAN), a complement-mediated disease,” the company says. The study is continuing in a double-blind design to evaluate iptacopan’s ability to slow IgAN progression by measuring estimated glomerular filtration rate slope over 24 months – the primary endpoint with topline results expected in 2025, it adds.

Novartis says there is a need for effective, targeted therapies for IgAN that slow or prevent progression to kidney failure. “Although current supportive care and treatment can help, they don’t address a key pathogenic step in the progression of IgAN: activation of the complement system,” it says, adding that iptacopan aims to address IgAN and other complement-mediated diseases by inhibiting factor B, a protease essential to the alternative complement pathway.