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Home Industry News Roche’s MabThera granted positive opinion in Europe

Roche’s MabThera granted positive opinion in Europe

23rd January 2009

Roche has announced its MabThera drug has been granted positive opinion from the European Union’s Committee on Human Medicinal Products.

The product – used in conjunction with chemotherapy as an initial treatment – is used as a therapy for people suffering from lymphocytic leukaemia.

The company noted the drug’s backing followed a CLL8 study, which found the drug prolonged the amount of time – 40 months instead of 32 months – until patients had a relapse or died.

William Burns, chief executive officer of Roche’s pharmaceuticals subsidiary, said the product “provided hope” for sufferers of a disease that is life threatening and incurable.

MabThera is currently licensed in Europe for the treatment of non-Hodgkin’s lymphoma.

Last month, research of patients with early rheumatoid arthritis revealed the drug also inhibited the progression of structural damage to joints, when used with methotrexate.

The Image study found the combination was more effective than treatment using methotrexate on its own.

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