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European Commission approves Roche’s MabThera (rituximab) for a rare autoimmune disease

European Commission approves Roche’s MabThera (rituximab) for a rare autoimmune disease
European Commission approves Roche’s MabThera (rituximab) for a rare autoimmune disease (Bild: Roche)

2019-03-15 10:20:24
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Durch die Nutzung dieser Webseite erklären Sie sich damit einverstanden. The European approval is based on data from the phase III Ritux 3 trial, a Roche-supported randomised controlled study, conducted in France, which evaluated MabThera plus a tapering regimen of oral corticosteroids (CS) compared to a standard dose of CS alone, as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus.

The primary endpoint of the study was complete remission at month 24 without the use of CS for two or more months. The study demonstrated that 89.5% of people with PV treated with MabThera, in combination with short-term oral CS treatment, achieved complete remission without the use of CS for two or more months, compared to 27.8% of people with PV receiving CS alone, the current standard of care.MabThera (Rituxan in the US) 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, in combination with glucocorticoids, is indicated for the treatment of adults with severe, active granulomatosis with polyangiitis (Wegener’s, GPA) and microscopic polyangiitis (MPA). People with serious infections should not receive MabThera/Rituxan.

It is not known if MabThera/Rituxan is safe or effective in children.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) and microscopic polyangiitis (MPA). 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. 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. 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 tenth consecutive year, Roche has been recognised as the most sustainable company 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 Medscape.

Pemphigus Vulgaris. [Internet; cited March 2019].

Available from: International Pemphigus & Pemphigoid Foundation. Pemphigus.

[Internet; cited March 2019] Available from: European Medicines Agency. Summary of Product Characteristics for MabThera.

[Internet; cited March 2019]. Available from: Joly P, et al.

First-Line Rituximab Combined with Short-Term Prednisone Versus Prednisone Alone for the Treatment of Pemphigus (Ritux 3): A Prospective, Multicentre, Parallel-Group, Open-Label Randomised Trial. The Lancet.

March 22, 2017.ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV).

[Internet; cited March 2019]. Available from: Murrell DF, et al.

Diagnosis and Management of Pemphigus: recommendations by an International Panel of Experts. Journal of the American Academy of Dermatology.

February 10, 2018.Skin Support, British Association of Dermatologists. Pemphigus Vulgaris.

[Internet; cited March 2019]. Available from: .

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European Commission approves Roche’s MabThera rituximab rare autoimmune disease