Astrazeneca's Ultomiris Receives FDA Priority Review for IgA Nephropathy

MT Newswires Live06-15

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.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment