Novartis Says FDA Gives Accelerated Approval for Kidney-Disease Treatment

By Connor Hart

Novartis said it received accelerated approval from the U.S. Food and Drug Administration for a treatment to bring down elevated levels of protein in the urine of adults who have a rare kidney disease.

The approval follows a Phase 3 study in which the treatment, Fabhalta, achieved a 44% reduction in this elevated protein level, called proteinuria, at nine months relative to baseline in patients with primary immunoglobulin A nephropathy, or IgAN. This reduction in protein compared with a 9% drop in the placebo arm, the Swiss pharmaceutical company said Wednesday.

Up to half of IgAN patients with persistent proteinuria progress to kidney failure within 10-20 years of diagnosis, Novartis said.

The continued approval of this first-in-class treatment may be contingent on a continuing Phase 3 study evaluating whether the treatment slows disease progression, data from which is expected to be released next year.

Write to Connor Hart at connor.hart@wsj.com

(END) Dow Jones Newswires

August 07, 2024 20:17 ET (00:17 GMT)

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