EU grants licence on Cystic Fibrosis drug Orkambi for prescription to children as young as six

EU grants licence on Cystic Fibrosis drug Orkambi for prescription to children as young as six

The EU has granted a licence to extend the use of the cystic fibrosis drug Orkambi to children as young as six-years-old.

The high price of the drug led to a stand-off between the Government and pharmaceutical company Vertex last year.

Clinical trials have indicated that the drug can slow the progression of the debilitating lung condition and can significantly improve the quality of life of patients.

The stand-off led to significant protests with patients demanding the drug be made available.

The HSE reached an agreement on the 'commercial terms' for supplying Orkambi to patients in Ireland with Vertex in April.

When the deal was agreed the drug was only licensed to patients of 12-years-old and over, however the EU has now extended permission for its use in patients aged 6 to 11-years-old.

In a statement this morning, Vertex said the deal included its extension to other age groups subject to European authorisation.

The company has pledged to “work closely with the HSE” to ensure younger patients are granted access as soon as possible, adding “we hope it will be made available shortly.”


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