European Union: European Commission Approval To Rituximab Is First Biologic Treatment For A Rare Autoimmune Disease

Last Updated: 17 April 2019
Article by Singh & Associates

Most Read Contributor in India, April 2019

On March 15, 2019 European Commission has approved Roche's MabThera® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare condition characterized by progressive painful blistering of the skin and/or mucous membranes. Extensive blistering can lead to serious, life-threatening fluid loss, infection and/or death13.

MabThera is the first biologic therapy approved by the European Commission for PV and the first major advancement in the treatment of the disease in more than 60 years.

The approval of MabThera 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.

About MabThera?

MabThera (rituximab) is the first therapeutic monoclonal antibody to target cells that have the CD20 marker on their surface. These cells are central to many blood cancers, including common forms of lymphoma and leukaemia. MabThera attacks these cells both directly and together with the body's immune system. MabThera is already approved to treat four autoimmune diseases:

  • Rheumatoid arthritis: MabThera 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.
  • Granulomatosis with polyangiitis and microscopic polyangiitis: 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
  • Chronic lymphocytic leukaemia (CLL): MabThera in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL.
  • Non-Hodgkin's lymphoma (NHL): MabThera is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy. MabThera is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisolone) chemotherapy.

About pemphigus vulgaris (PV)

Pemphigus vulgaris is an autoimmune, blistering disease, occurring within the epidermis, affecting the skin and mucous membranes. It is the most common type of a group of autoimmune disorders collectively called pemphigus. It is estimated that around three in every 100,000 people are diagnosed with this disease globally.

Note- MabThera is marketed as Rituxan in in the United States, Japan and Canada. Following approval by EC the MabThera is now approved to treat four autoimmune diseases in the US and Europe.

Footnote

13 https://www.roche.com/media/releases/med-cor-2019-03-15.htm

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