AstraZeneca wins new FDA approval for serious kidney disease
A new treatment indication has opened up for AstraZeneca’s Ultomiris following positive results from a phase III trial. The FDA has approved the drug for a rare kidney disease, although its long-term clinical benefits have yet to be established.
The accelerated approval covers Ultomiris (ravulizumab) for reducing proteinuria, or elevated levels of protein in the urine, in adults with primary IgA nephropathy who are at risk of disease progression.
The decision is based on an interim analysis of the phase III I CAN trial, in which treatment reduced proteinuria by 43.4 per cent compared with placebo after 34 weeks, according to a press release issued by AstraZeneca on Wednesday.
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