By Giulia Petroni

 

Novartis will submit an application next year for a possible accelerated approval of atrasentan in the U.S. after its phase 3 study met the primary endpoint.

The Swiss pharmaceutical company said Monday that the study showed a significant reduction in proteinuria, a condition causing high levels of protein in urine, in patients with kidney disease IgA nephropathy.

Novartis plans to review interim results with the U.S. Food and Drug Administration for a potential regulatory submission for accelerated approval. The study will continue, with final readout expected in the first quarter of 2026, it said.

 

Write to Giulia Petroni at giulia.petroni@wsj.com

 

(END) Dow Jones Newswires

October 30, 2023 02:52 ET (06:52 GMT)

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