Novartis: Phase III Study Shows Superiority Of Iptacopan In Patients With C3 Glomerulopathy

(RTTNews) - Novartis (NVS) reported positive topline results from the six-month, double-blind period of the Phase III APPEAR-C3G study of iptacopan for the treatment of patients with C3 glomerulopathy. The study met primary endpoint, with iptacopan showing superiority compared to placebo in providing clinically meaningful and statistically significant proteinuria reduction on top of background therapy at six months. The safety profile was consistent with previously reported data, the company said. The company plans to review results with global health authorities to enable potential submissions in 2024.

On December 5, the FDA approved iptacopan, under the brand name Fabhalta, as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria , and it is currently being reviewed by the EMA for the same indication.

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