Novartis to seek accelerated approval for oral complement inhibitor in rare kidney disease
Novartis said that its experimental complement inhibitor iptacopan reduced the buildup of protein in the urine of patients with IgA nephropathy significantly more than a placebo, and now the Swiss pharma company plans to apply for accelerated approval with the FDA next year.
Novartis measured the level of protein in urine — a biomarker of kidney function decline — at nine months for the Phase III interim analysis, it announced Monday. The data suggest that iptacopan beat placebo on top of supportive care for patients with the rare kidney disease.
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