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Medical Daily
Medical Daily
Elena Vega

Gazyva Wins FDA Approval for Childhood-Onset Nephrotic Syndrome, Giving Families a New Option to Reduce Relapses

Parents of children who go through one steroid course after another for nephrotic syndrome have a new option to discuss with their child's kidney doctor. The Food and Drug Administration approved Gazyva (obinutuzumab) to reduce relapse risk on Sept. 25. The approval covers children and adults 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission.

Genentech, which makes the drug, calls it the first FDA-approved treatment for the condition in 70 years. Gazyva does not replace steroids for an active flare, and it carries serious safety warnings that families need to weigh.

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