Minister for Health Simon Harris has welcomed the extension of the availability of ORKAMBI to eligible children aged 6-11 years with Cystic Fibrosis.
This comes following EMA approval in January of this year. The 2017 agreement between the manufacturer, Vertex Pharmaceuticals and the HSE included the extension to other age groups, subject to market authorisation in Europe.
“It’s very positive news that ORKAMBI is now licensed and available for reimbursement in Ireland for Cystic Fibrosis patients aged 6 to 11,” Minster Harris said.
“ORKAMBI was already licensed and available for reimbursement for children aged 12 years and over. The extension to the younger children became possible following EMA approval in January of this year. This quick turnaround between approval and availability was possible because we ensured the younger age group was included in the agreement with the company Vertex last year, subject to market authorisation in Europe.
“I am very pleased that Ireland is one of the first countries in the European Union to provide access to ORKAMBI for children in this age category,” Minster Harris added.
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