Roche’s MabThera (rituximab) Receives EU’s Approval for Rare Autoimmune Disease Pemphigus Vulgaris (PV)

Shots:

• The EU approval is based on P-III Ritux 3 study assessing MabThera + oral Corticosteroids (CS) vs CS as monothx.in patients with 1L moderate to severe pemphigus vulgaris (PV) in France
• The P-III Ritux 3 study results: met its 1EPs; achieved complete remission @24mos.; remission @2mos. (89.5% vs 27.8%); published in The Lancet in Mar’17
• MabThera (Rituxan in the US) is a novel mAb target cancer cells with CD20 marker on their surface in patients with severe active RA in combination with methotrexate and is approved in the US in Jun’18 for PV

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