Orphan designation: Brentuximab vedotin Treatment of cutaneous T-cell lymphoma, 11/01/2012 Withdrawn
At the time of designation, CTCL affected less than 2.2 in 10,000 people in the European Union (EU). This was equivalent to a total of fewer than 112,000 people*, and is below the ceiling for orphan designation, which is 5 people in 10,000. This is based on the information provided by the sponsor and the knowledge of the Committee for Orphan Medicinal Products (COMP).
*Disclaimer: For the purpose of the designation, the number of patients affected by the condition is estimated and assessed on the basis of data from the European Union (EU 27), Norway, Iceland and Liechtenstein. At the time of designation, this represented a population of 509,000,000 (Eurostat 2012).
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