Novartis Says Kidney Drug Phase 3 Trial Reaches Positive Interim Result
02 Ottobre 2023 - 8:10AM
Dow Jones News
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 adria.calatayud@dowjones.com
(END) Dow Jones Newswires
October 02, 2023 01:55 ET (05:55 GMT)
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