AstraZeneca's Ultomiris Wins FDA Approval to Reduce Proteinuria in IgAN Patients

MT Newswires Live10-22

AstraZeneca's (AZN) Alexion unit's Ultomiris received the US Food and Drug Administration accelerated approval to reduce proteinuria in adults with primary IgA nephropathy at risk of disease progression, the company said late Wednesday.

The approval was based on a prespecified interim analysis of the phase III I CAN trial, which showed Ultomiris reduced proteinuria by 43.4% versus placebo at 34 weeks. The treatment is administered intravenously every eight weeks following a loading dose.

The ongoing trial will assess kidney function at week 106 to support potential traditional FDA approval, with late-breaking results due Oct. 23 at the American Society of Nephrology's Kidney Week, the company added.

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