FDA expands treatment in nephrotic syndrome

The indication marks an additional use for a therapy previously approved for certain cancers and active lupus nephritis.

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The FDA approved obinutuzumab (Gazyva) for reducing relapse risk in patients aged 2 and older with frequently relapsing idiopathic nephrotic syndrome.
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Idiopathic nephrotic syndrome causes urinary protein loss, low blood albumin, and can lead to complications like high cholesterol and infections.
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The condition primarily affects pediatric patients, typically developing between ages 2 and 7, with an annual incidence of 1 to 4 cases per 100,000.
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Efficacy of obinutuzumab was evaluated in the INSHORE trial, showing a statistically significant improvement over standard treatment.
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Obinutuzumab carries warnings for hepatitis B virus reactivation and progressive multifocal leukoencephalopathy, with common side effects including infections.

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