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EC Approves Roche's MabThera For Rare Autoimmune Disease

Roche (RHHBY) said that the European Commission has approved MabThera or rituximab for the treatment of adults with moderate to severe pemphigus vulgaris or PV, a rare condition characterised by progressive painful blistering of the skin and/or mucous membranes. Extensive blistering can lead to serious, life-threatening fluid loss, infection and/or death.

MabThera is the first biologic therapy approved by the European Commission for PV and the first major advancement in the treatment of the disease in more than 60 years. Following approval by the US Food and Drug Administration (FDA) in June 2018 and today's decision, MabThera is now approved to treat four autoimmune diseases in the US and Europe.

Pemphigus vulgaris is an autoimmune, blistering disease, occurring within the epidermis, affecting the skin and mucous membranes.It is the most common type of a group of autoimmune disorders collectively called pemphigus. It is estimated that around three in every 100,000 people are diagnosed with this disease globally.

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