FDA grants priority review to Roche ’s Mabthera/Rituxan (rituximab) in children with two rare blood vessel disorders

Roche announced today that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) and granted Priority Review for the use of MabThera®/Rituxan® (rituximab), in combination with glucocorticoids (GCC), for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children two years of age a nd older.
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news