The first rare vasculitis drug! Rituxan is recommended and approved by CHMP for several pediatric indications, including 2 kinds of vasculitis!

February 5, 2020 / BIOON/ --The European Medicines Administration (EMA) Committee on human medicinal products (CHMP) recently issued a positive review opinion, suggesting that the marketing authorization application (MAA) of mabthera (rituximab) in Europe should be approved and expanded: (1) mabthera should be used in combination with glucocorticoids for severe and active granulomatosis Patients with vasculitis (GPA) and microangitis (MPA) in Pediatrics (2 years old ≤ age < 18 years old) induced remission (2) Mabthera combined with chemotherapy was used to treat advanced CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL) / Burkitt leukemia (BAL) or Burkitt like lymphoma (BLL) in pediatric patients (primary treatment) who were not treated before (6 months ≤ age < 18 years) Mabthera's active drug ingredient is rituximab, a therapeutic monoclonal antibody targeting CD20, which can mobilize the body's natural defense, attack and kill the labeled CD20 positive B cells At present, mabthera has been approved to treat many types of non Hodgkin's lymphoma (NHL), such as follicular lymphoma (FL), CD20 positive diffuse large B cell lymphoma (DLBCL), and chronic lymphoblastic leukemia (CLL) In addition, mabthera has been approved for treatment of various types of autoimmune diseases, including rheumatoid arthritis (RA), granulomatous polyangitis (GPA), microscopic polyangitis (MPA), pemphigus vulgaris (PV) It is worth mentioning that mabthera / rituxan (rituximab) is the first biotherapy approved for the treatment of pemphigus vulgaris (PV), which was approved in the United States and the European Union in June 2018 and March 2019, marking the first significant progress in the clinical treatment of PV in more than 60 years At the end of September 2019, rituxan (rituximab) was again approved by the US FDA, combined with Glucocorticoid (GCC), for the treatment of GPA and MPa in children aged 2 and above It is worth mentioning that rituxan is the first and only FDA approved drug for the treatment of GPA and MPa in pediatric patients aged 2 years and over GPA and MPA are two rare and potentially life-threatening vasculitis that affect small and medium vessels The indication was approved through the FDA's priority review process and marks the first pediatric indication of rituxan GPA and MPA are two kinds of antineutrophil cytoplasmic antibody (ANCA) - associated vasculitis (AAV) AAV is a kind of vasculitis, which mainly affects small blood vessels In general, GPA and MPA affect small blood vessels in kidneys, lungs, sinuses and various other organs, but these diseases may have different effects on each patient Both GPA and MPA are considered rare diseases, with an estimated global prevalence of 23-160 cases per million people GPA and MPA cases in childhood are more rare and associated with severe, potentially life-threatening symptoms Original source: mabthera: pending EC decision | European Medicine Agency