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

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