Novartis Drug Meets Primary Goal in Late-Stage Study for Kidney Disease

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 [e-mail]

(END) Dow Jones Newswires

December 11, 2023 01:47 ET (06:47 GMT)

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