Orphan designation: sotatercept Treatment of pulmonary arterial hypertension, 09/12/2020 Positive
At the time of designation, pulmonary arterial hypertension affected approximately 1.4 in 10,000 people in the European Union (EU). This was equivalent to a total of around 73,000 people1, and is below the ceiling for orphan designation, which is 5 people in 10,000. This isbased on the information provided by the sponsor and the knowledge of the Committee for Orphan Medicinal Products (COMP).
1For 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, Iceland, Liechtenstein, Norway and the United Kingdom. This represents a population of 519,200,000 (Eurostat 2020).
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