Orphan designation: Diacerein Treatment of epidermolysis bullosa, 20/02/2014 Positive
At the time of designation, epidermolysis bullosa affected approximately 0.25 in 10,000 people in the European Union (EU). This was equivalent to a total of around 13,000 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 28), Norway, Iceland and Liechtenstein. This represents a population of 511,100,000 (Eurostat 2014).
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