Positive Interim Results from Phase 3 Trial of Iptacopan in Kidney Disease Nephropathy

Novartis, a leading Swiss pharmaceutical company, has reported positive findings from an interim analysis of a phase 3 trial evaluating its investigational drug, iptacopan, in patients with kidney disease nephropathy. The analysis, conducted at the nine-month mark, demonstrated a significant reduction in protein in urine, a key indicator of disease progression.

The results of the study showed that iptacopan outperformed placebo in reducing protein in urine, indicating its potential effectiveness in managing the disease. Moreover, the safety profile of the drug remained consistent with previously reported data.

Following these promising results, Novartis intends to discuss the interim findings with the U.S. Food and Drug Administration (FDA) in order to pursue accelerated approval. This regulatory submission could pave the way for iptacopan's introduction as a new treatment option for patients with kidney disease nephropathy.

The trial will now continue to evaluate iptacopan's ability to slow disease progression over a two-year period. Final results regarding the primary goal of the study are expected to be available in 2025.

Overall, these interim findings highlight the potential of iptacopan as a novel therapeutic solution for patients suffering from kidney disease nephropathy. Novartis remains committed to advancing medical research and bringing innovative treatments to patients in need.