AstraZeneca says FDA approves drug for rare kidney disease in adults

AstraZeneca says FDA approves drug for rare kidney disease in adults

Transforming the IgA Nephropathy Treatment Landscape

For decades, patients diagnosed with IgA nephropathy—an autoimmune condition where trapped immune complexes inflame and damage the kidney’s filtering units (glomeruli)—faced a discouraging outlook. Typically diagnosed in young adults aged in their 20s or 30s, the disease often resulted in kidney failure and a dependence on dialysis within their lifetime due to a lack of […]

FDA Grants Ultomiris Accelerated Approval in the U.S. for Adults with Primary Immunoglobulin A Nephropathy

FDA has granted accelerated approval to Ultomiris based on Phase III data showing a 43.4% placebo-adjusted reduction at 34 weeks.

AstraZeneca’s Ultomiris gains US accelerated approval for reducing proteinuria in adults with IgA nephropathy

FDA decision follows Phase III I CAN interim data showing a 43.4% placebo-adjusted reduction in proteinuria at week 34; kidney-function benefit remains unestablished IN BRIEFKEY TAKEAWAYSFAQs Alexion, AstraZeneca Rare Disease, has announced US FDA accelerated approval of Ultomiris (ravulizumab) to … Read the full press release →