Roche: Rituxan approved for two paediatric illnesses

(CercleFinance.com) - Roche announces that the US FDA has approved Rituxan (rituximab), combined with glucocorticoids, to treat granulomatosis with Polyangiitis and microscopic polyangiitis in paediatric patients who are two years of age and older.


The Swiss pharmaceutical company says that this is the first and only drug approved for paediatric patients suffering from these two rare, life-threatening diseases affecting small and medium blood vessels.

This approval is based on data from the Phase IIa PePRS study. It comes as part of a priority review in paediatric patients that was previously granted by the US health authority.


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