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 [email protected]
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