Swiss pharma giant Roche has announced that the European Commission (EC) has approved its drug MabThera (rituximab) for rare autoimmune disease pemphigus vulgaris (PV).
This makes MabThera the first biologic to be approved in the European Union for this indication.
The recommendation was based upon a France-based Roche-sponsored Phase III trial named Ritux, which compared MabThera in combination with the current standard of care, corticosteroids, to the steroids alone.
The primary endpoint was remission at 24 months without the use of corticosteroids for at least two months. Results showed 89.5% of participants receiving MabThera achieved the endpoint, compared to 27.8% taking the corticosteroids.
Roche chief medical officer and head of global product development Sandra Horning said: “We’re pleased to bring the first biologic medicine to the more than 50,000 people in Europe suffering from pemphigus vulgaris.
“This MabThera approval provides a much needed new treatment that has been shown to provide higher remission rates than corticosteroids alone, which can cause debilitating side effects.”
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Roche is currently investigating MabThera’s efficacy and safety compared to immunosuppressant mycophenolate mofetil for PV.
PV involves progressive painful blistering of the skin and mucuous membranes, which can lead to life-threatening fluid loss, infection and death.
MabThera was approved for PV by the US Food and Drug Administration in June 2018. It is also approved in both Europe and the US for three blood cancers: relapsed follicular lymphoma, previously untreated diffuse large B-cell lymphoma and chronic lymphocytic leukaemia.
Combined with methotrexate MabThera is also indicated in the US for rheumatoid arthritis and combined with glucocorticoids is indicated for the treatment of adults with severe, active granulomatosis with polyangiitis and microscopic polyangiitis.
The drug is a monoclonal antibody that targets cells with a CD20 marker on their surface, which include normal B cells. It attacks these cells in collaboration with the body’s immune system.