FDA grants Breakthrough Therapy Designation for Roche?s Gazyva (obinutuzumab) in Lupus Nephritis
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
- There are currently no U.S. FDA-approved medicines for lupus nephritis
- The designation is based on the results of the phase II NOBILITY study that showed Gazyva, in combination with standard of care, helped more people achieve a complete renal response than standard of care alone
- Full results from the NOBILITY study will be presented at a medical meeting later this year
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