FDA Grants Priority Review To Roche's Gazyva/Gazyvaro, Potential First Therapy For Primary Membranous Nephropathy, After Phase III MAJESTY Showed Superior Remission Versus Tacrolimus

ROCHE HOLDINGS AG
ROCHE HOLDINGS AG
ROCHE HOLDINGS AG

ROCHE HOLDINGS AG

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ROCHE HOLDINGS AG

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  • Priority Review decision is based on phase III MAJESTY results, where Gazyva/Gazyvaro achieved significantly higher complete remission rates at two years compared to tacrolimus1
  • If approved, Gazyva/Gazyvaro will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome
  • pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years2,3
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