- 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
Click here to read full press release/ article | Ref: Roche | Image: Pharmaceutical Technology