MABTHERA (rituximab), monoclonal antibodies
RARE DISEASE - New indication
Opinions on drugs -
Posted on
Apr 16 2015
- Updated on
Mar 17 2016
Reason for request
Extension of indication
Minor improvement in the remission induction strategy for granulomatosis with polyangiitis and severe active microscopic polyangiitis
MABTHERA now has Marketing Authorisation, in combination with glucocorticoids, in remission induction therapy in adult patients with granulomatosis with polyangiitis (GPA) and severe active microscopic polyangiitis (MPA).
It has a potential benefit relative to oral cyclophosphamide in patients in relapse.
There was no evidence of impact on fertility in patients of childbearing age.
Clinical Benefit
Substantial |
- |
Clinical Added Value
minor |
- |
Therapeutic use
- |
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