FDA approves Roche?s Rituxan (rituximab) in children with two rare blood vessel disorders
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
Rituxan is the first and only FDA-approved treatment for paediatric patients 2 years of age and older living with granulomatosis with polyangiitis or microscopic polyangiitis
- These two forms of vasculitis in children are rare and associated with severe, potentially life-threatening symptoms
- This approval is the first paediatric indication for MabThera/Rituxan
About Granulomatosis with Polyangiitis and Microscopic Polyangiitis
Granulomatosis with polyangiitis (GPA) (formerly known as Wegener's Granulomatosis) and microscopic polyangiitis (MPA) are two types of ANCA-associated vasculitis (AAV). AAV is a form of vasculitis, or blood vessel inflammation, that primarily affects small blood vessels. In general, GPA and MPA both affect the small blood vessels of the kidneys, lungs, sinuses, and a variety of other organs, but the diseases may affect each person differently. Both GPA and MPA are considered rare diseases, with an estimated prevalence globally of 23 to 160 cases per million in the population. Cases of paediatric onset GPA and MPA are even more rare and are associated with severe, potentially life-threatening symptoms.About MabThera/Rituxan in Immunology
MabThera (Rituxan in the US) is indicated for the treatment of four autoimmune conditions. MabThera/Rituxan in combination with glucocorticoids, is indicated for the treatment of granulomatosis with polyangiitis (Wegener?s granulomatosis, GPA) and microscopic polyangiitis (MPA) in adults. Rituxan, in combination with glucocorticoids, is also indicated for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in paediatric patients 2 years of age and older. MabThera/Rituxan in combination with methotrexate, is indicated for the treatment of adults with severe active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD), including one or more tumour necrosis factor (TNF) inhibitor therapies. MabThera/Rituxan is indicated for the treatment of adults with moderate to severe pemphigus vulgaris (PV). People with serious infections should not receive MabThera/Rituxan. MabThera/Rituxan is not indicated in children less than 2 years of age with GPA or MPA, or in children with conditions outside of GPA and MPA.About Roche in rheumatology and beyond
For more than 50 years, Roche has followed the science to pioneer medicines for immune-mediated rheumatic diseases. First-in-class anti-IL-6 receptor therapy Actemra?/RoActemra??(tocilizumab) has treated more than one million people with debilitating conditions, such as rheumatoid arthritis (RA), polyarticular and systemic juvenile idiopathic arthritis, giant cell arteritis and chimeric antigen receptor T-cell-induced cytokine release syndrome. MabThera?/Rituxan??(rituximab), which targets CD20, has significant clinical and real-world experience treating rheumatic conditions including RA, granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and pemphigus vulgaris (PV). Roche aims to provide solutions for people that need new treatments most, particularly those with severe or life-threatening conditions and limited treatment options. Our pipeline consists of treatments designed to target immune pathways including a glycoengineered type II anti-CD20 antibody in lupus nephritis.About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people?s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare ? a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world?s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit?www.roche.com.All trademarks used or mentioned in this release are protected by law.