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Genentech: FDA Grants Priority Review For Rituxan In Pediatric Indication

Genentech, a member of the Roche Group (RHHBY), said the FDA has granted priority review for Rituxan (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in children above two years of age. Rituxan is currently approved for the treatment of four autoimmune indications.

The FDA accepted the company's sBLA which was based on data from the PePRS study, a Phase IIa, global study investigating intravenous Rituxan in 25 patients between six and 17 years of age.

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