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

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

Shots:

  • 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

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