Astrazeneca's Ultomiris Receives FDA Priority Review for IgA Nephropathy

MT Newswires Live
06/15

AstraZeneca (AZN) said Monday that the US Food and Drug Administration has accepted and granted priority review to its supplemental marketing application for the experimental drug Ultomiris for the treatment of adults with immunoglobulin A nephropathy.

The company said the FDA is expected to make a decision in Q4.

AstraZeneca added that the application is supported by interim results from a phase III trial showing that Ultomiris reduced proteinuria, as measured by the 24-hour urine protein-to-creatinine ratio, by 46.6% from baseline, compared with a 5.6% reduction for placebo, resulting in a placebo-adjusted treatment effect of 43.4%.

Reductions in proteinuria were observed as early as Week 10 and were maintained through Week 34, the company said.

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