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Gazyva Succeeds In NOBILITY Lupus Nephritis Study But What Next?

 
• By Eleanor Malone

Genentech refrained from committing to further development of its CD20 inhibitor in the indication despite meeting endpoints in Phase II study.

Road_Arrows
Will Roche/Genentech proceed with Gazyva in lupus nephritis?

Genentech Inc.’s Gazyva (obinutuzumab) has met the primary endpoint in a Phase II trial studying it in adults with proliferative lupus nephritis, a severe kidney complication of the autoimmune disease systemic lupus erythematosus (SLE) for which there are no approved therapies in the US or EU.

The CD20-targeting drug, which was first approved by the US Food and Drug Administration in 2013 for chronic lymphocytic leukemia (winning subsequent approval in follicular lymphoma), demonstrated enhanced efficacy in achieving complete renal response at one year when combined with standard-of-care treatments, compared with placebo plus standard of

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REGENCY Dandy for Roche In Lupus Nephritis

 
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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.    

AstraZeneca Believes Size Matters In Amyloidosis

 
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• By Andrew McConaghie

The big pharma’s second selection in the alliance shows novel cardiovascular therapies are high on its priority list

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• By Andrew McConaghie

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