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REGENCY Dandy for Roche In Lupus Nephritis

 
• By Elizabeth Cairns

Gazyva could add the autoimmune condition to its label following a Phase III hit, but it might struggle to differentiate itself from Benlysta and Lupkynis.    

Blue and purple graphic image of pair of kidneys
• Source: Shutterstock

Roche Holding AG could be third to market in the autoimmune disease lupus nephritis after claiming a topline hit in the pivotal REGENCY trial. More people responded to the anti-CD20 antibody in the Phase III study than responded to placebo, and Roche intends to get the drug on the market in this new use “as soon as possible”.

Key Takeaways
  • Roche’s anti-CD20 antibody Gazyva has posted a topline hit in its pivotal lupus nephritis trial, though details of its efficacy have not been released.
  • It will have to beat the two marketed products, GSK’s Benlysta and Aurinia and Otsuka’s Lupkynis, to give doctors a reason to switch their patients over

The company has not yet disclosed the actual figures for the hit, so it is not possible to say how it stacks up against the two approved lupus nephritis therapies, GSK plc’s Benlysta (belimumab) and Aurinia Pharmaceuticals Inc. and Otsuka Holdings Co., Ltd.’s Lupkynis (voclosporin)

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