A supplementary biologics license from Roche Rituxan is accepted by the FDA

GPA and MPA are two types of ANCA-associated vasculitis (AAV)AAV is an vasculitis that mainly affects small blood vesselsIn general, GPA and MPA affect small blood vessels in the kidneys, lungs, sinuses and various other organs, but these diseases can have a different effect on each patient, Roche, thegiant ofpharmaceutical(http:// in Switzerland, announced that theAuthority of theof food anddrugs (http://fda)(
FDA) (http://had accepted and granted priority review to Rituxan (the generic name: rituximab, litoseibeia)the sBLA application for approval of Rituxan combined glucocorticoids (GCC) for use in children 2 years and older, to treat accompanying granuloma polyvascularitis (GPA) and sub-microscope polyvascularitis (MPA)About Rituxan
Rituxan is a therapeutic monoclonal antibody that targets CD20 antigens that bind to normal and malignant B cell surfaces and then mobilizes the body's natural defenses to attack and kill labeled B cells so far, Rituxan has been approved to treat four autoimmune diseases in adults, including rheumatoid arthritis (RA), GPA, MPA, and common herpes (PV) If approved, the sBLA will be Rituxan's first paediatric indication 　　The sBLA, based on data from the PePRS study, is the first global study to evaluate Rituxan's treatment of GPA or MPA pediatric patients the study, a global, open label, single arm, IIa phase study, involved 25 patients aged 6-17 with severe, new, or recurrent active GPA or MPA, assessing the safety, pharmacology/pharmacokinetics and exploratory efficacy of the Rituxan Joint GCC program