Priority Review for Genentech Rituxan sBLA

FDA has accepted for priority review a Genentech supplemental BLA for Rituxan (rituximab) for combination use with glucocorticoids for treating granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children two years of age and older. GPA and MPA are rare, potentially life-threatening diseases affecting small and medium sized blood vessels, the company says.

The submission was based on data from the PePRS study, a Phase 2a trial investigating the safety, pharmacodynamics/pharmacokinetics and exploratory efficacy of intravenous Rituxan in 25 patients with severe GPA or MPA between six and 17 years of age, Genentech says. Rituxan is currently indicated for treating four autoimmune conditions. The agency approved Rituxan for rheumatoid arthritis in 2006, treating adults with GPA and MPA in 2011, and for treating adults with pemphigus vulgaris in 2018.