Genentech Reports Acceptance of sBLA for Rituxan (rituximab) to Treat Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) in Children with 2 Years and Older
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- The sBLA submission is based on P-IIa PePRS study results assessing Rituxan (IV) + tapering course of oral glucocorticoids in 25 patients with severe GPA or MPA aged b/w 6 to 17 years of age
- Rituxan has also received Priority Review Designation in combination with glucocorticoids (GCC)- for treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2yrs. and older
- Rituxan (rituximab) is a mAb used to target cancer cells with CD20 marker and has received FDA’s approval for rheumatoid arthritis (RA) in 2006- for adults with GPA and MPA in 2011- for adults with pemphigus vulgaris in 2018
Ref: Genentech | Image: Law
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