Hundreds of patients with cystic fibrosis (CF) should have access to new treatments after they have approved the new drug for use in Ireland.
Vertex Pharmaceuticals has claimed that Symkevi, a 12-year-old and older, has received a European market access.
Histological fibrosis is an inherited disease commonly associated with internal organs leading to frequent or severe infections, especially for the lungs and digestive tract.
It is associated with a defective gene that controls the movement of salts and water in the body and outside of the body and influences more than 1100 people in Ireland.
The EU regulatory decision will lead to Irish patients who will have access to a new drug.
"I am glad that Ireland and its families have approved new treatments for patients with SN," Minister of Health Simon Harris said on Friday.
"Next week, HSE will work with Vertex to ensure timely access to these new treatments for Irish patients. This is a very important development and important day for patients with mystical fibrosis. "