Novartis Drug Meets Primary Goal in Late-Stage Study for Kidney Disease
11 Dicembre 2023 - 8:02AM
Dow Jones News
By Adria Calatayud
Novartis's investigational drug iptacopan achieved its primary
goal in a late-stage clinical trial for treatment of kidney disease
C3 glomerulopathy, paving the way for potential submissions to
health authorities next year.
The Swiss pharmaceutical giant said Monday that a phase 3 study
of iptacopan met its primary goal of demonstrating a statistically
significant reduction of protein in urine compared to placebo at
six months. The safety profile of the drug was consistent with
previously reported data, the company said.
Novartis said it plans to review and discuss the results with
global health authorities and that it anticipates potential
regulatory submissions in 2024. Data will be submitted as well for
presentation at an upcoming medical meeting, it said.
Iptacopan is also being investigated in other diseases. Last
week, the U.S. Food and Drug Administration approved the
drug--under the brand name Fabhalta--for the treatment of adults
with paroxysmal nocturnal hemoglobinuria, the company said.
Write to Adria Calatayud at adria.calatayud@dowjones.com
(END) Dow Jones Newswires
December 11, 2023 01:47 ET (06:47 GMT)
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