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Positive Topline Phase III Results Bring Otsuka Drug Closer To IgAN Finish Line

 
• By Alaric DeArment

The company announced positive interim results for sibeprenlimab, one of seven IgAN candidates in late-stage development from multiple manufacturers.

Kidneys made of pills on blue background
• Source: Shutterstock

With now three drugs for immunoglobulin A nephropathy (IgAN) having US Food and Drug Administration approval, the disease has become a competitive space, one into which Otsuka Pharmaceutical Co. Ltd. is jumping with its own candidate, sibeprenlimab. It is one of more than half a dozen IgAN candidates in late-stage development and Otsuka plans to seek FDA approval on the back of successful Phase III topline interim results.

Key Takeaways
  • Otsuka said the Phase III VISIONARY study of sibeprenlimab in IgA nephropathy met its primary endpoint, with a statistically significant improvement in uPCR.

The drug maker said 22 October that the Phase III VISIONARY study of about 530 adult patients met its primary endpoint, with sibeprenlimab demonstrating a statistically significant and clinically meaningful...

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