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
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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).
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It has a potential benefit relative to oral cyclophosphamide in patients in relapse.
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There was no evidence of impact on fertility in patients of childbearing age.
Clinical Benefit
| Substantial |
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Clinical Added Value
| minor |
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Therapeutic use
|
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