NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

double that to include Europe, so ~ 28,000 cases a year.

11 February 2013 EMA/COMP/96767/2008 Rev.1 Committee for Orphan Medicinal Products.

What is the estimated number of patients affected by the condition?
At the time of designation, glioma affected approximately 1 in 10,000 people in the European Union (EU). This was equivalent to a total of around 46,000 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 500,300,000 (Eurostat 2007).

https://www.ema.europa.eu/documents/orphan-designation/eu/3/07/431-public-summary-positive-opinion-orphan-designation-autologous-dendritic-cells-pulsed-autologous_en.pdf