By Adria Calatayud Novartis said an interim analysis from a phase 3 trial to evaluate its investigational iptacopan drug in patients with kidney disease...
Novartis said an interim analysis from a phase 3 trial to evaluate its investigational iptacopan drug in patients with kidney disease nephropathy achieved positive results, meeting its primary goal.
The Swiss pharmaceutical company said Monday that an analysis of study data at nine months showed a clinically meaningful and statistically significant reduction in protein in urine. The company said this demonstrated superiority of iptacopan relative to placebo in reducing protein in urine.Novartis said it plans to review the trial's interim results with the U.S. Food and Drug Administration to enable a potential regulatory submission for accelerated approval.
The study will now continue to assess the iptacopan's ability to slow disease progression over two years, the company said. Results from the primary goal at the end of the study are expected in 2025.
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