Novartis Says Kidney Drug Phase 3 Trial Reaches Positive Interim Result

By Adria Calatayud

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.

The safety profile of the drug was consistent with previously reported data, Novartis said.

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.

Write to Adria Calatayud at [e-mail]

(END) Dow Jones Newswires

October 02, 2023 01:55 ET (05:55 GMT)

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