Novartis Says Drug Improves Kidney Function in Patients With Berger's Disease

MT Newswires Live03-30

Novartis AG (NVS) said Sunday that its drug Fabhalta showed "statistically significant, clinically meaningful improvement" in kidney function among patients with IgA nephropathy, or Berger's disease, in a phase three study.

The company said the drug decreased kidney function decline by 49.3% over two years compared with a placebo, "demonstrating a slowing of disease progression and the potential to preserve kidney function."

The company said the drug's safety profile over two years was consistent with other studies and that rates of adverse events and treatment discontinuation were low.

The Food and Drug Administration granted priority review for Fabhalta based on the strength of the data, the company added.

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