Roche’s Rituxan (rituximab) Receives the US FDA’s Approval for Two Rare Blood Vessel Disorders in Pediatric Patients Aged 2yrs. and Above

Shots:

• The FDA’s approval is based on P-IIa PePRS study assessing MabThera/Rituxan (IV) + glucocorticoids in 25 pediatric patients with active granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) aged 6-17yrs.
• The P-IIa PePRS study results: the achievement of PVAS remission @6mos. (56%); @12mos. (92%); @18mos. (100%); safety profile in pediatric patients with GPA & MPA is consistent with the safety profile in adult patients with GPA, MPA, RA & pemphigus Vulgaris
• Rituxan targets CD20, indicated to treat GPA & MPA in combination with glucocorticoids in adults & children & used to treat RA in combination with MTX and has received FDA’s PR designation for pediatric patients with GPA& MPA

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