The Health Service Executive has approved the only treatment on the market for the rare muscle-wasting disease Spinal Muscular Atrophy (SMA).
The approval of Spinraza follows a lengthy campaign by patients and their families.
SMA is a genetic condition that affects the nerves in the spinal cord. It causes problems with movement, muscle weakness and difficulty breathing and swallowing.
It is generally fatal for people with the most severe forms of the condition. It is estimated that there are approximately 25 children living with SMA in Ireland.
The Minister for Health confirmed the news on Twitter just before lunchtime.
Simon Harris acknowledged "how hard the long journey has been for families to get to this point" and he said he was "very glad children in Ireland will now have access to the drug".
Welcome news today that Spinraza is now approved by the HSE. This is the first ever treatment for children with SMA. I know how hard the long journey to get here has been for families but very glad children in Ireland will now have access— Simon Harris TD (@SimonHarrisTD) June 11, 2019
SMA Ireland also used Twitter to welcome the "positive announcement", but added that the group was awaiting the full details of the approval.
"All at SMA Ireland and all people with SMA are deeply concerned that the HSE/Government may apply an age based cut off to treatment to save costs," it said.
While we welcome this positive announcement by Minister @SimonHarrisTD we are still waiting for the full details of the approval.— SMA Ireland (@SMAIrelandCom) June 11, 2019
All at SMA Ireland and all people with SMA are deeply concerned that the HSE/Government may apply an age based cut off to treatment to save costs. https://t.co/ngjxRBBtQC
In a statement issued this afternoon, the HSE said the recommendation is to approve access for children under 18 years with genetically confirmed SMA Type I, II or III, in accordance with the controlled access criteria recommended by the Rare Diseases Technology Review Committee.
It said it will work closely with the Department of Health in relation to the funding implications of today's decision, particularly in relation to funding for future years.
Politicians from all parties have welcomed the decision since it was announced this afternoon.
Fianna Fáil’s health spokesperson said the approval by the HSE of Spinraza is a testament to the determination of patients and their families.
In a statement, Stephen Donnelly said: "This has been a long-fought battle by those suffering from the rare muscle-wasting disease, spinal muscular atrophy who rightly wanted the health service here to follow the example of almost every other European country and supply Spinraza."
Sinn Féin's Caoimhghín Ó Caoláin said: "It is without question a most important day for all the 25 children and their families who will now hopefully benefit directly from this decision.
"We have finally gotten to a point of approval for reimbursement after many long and hard days of protesting, campaigning and the unavoidable pain and tears."
Frank Browne, whose daughter Emma died from the disease in 2004, said that it has been a "rollercoaster" of a campaign.
Speaking on RTÉ's News at One, he said that the families and people involved in the campaign realise that Spinraza is an expensive drug. However, he said: "What is the price that we can put on life?"
Mr Browne said that he has been speaking to some of the families who campaigned for the drug and they are "celebrating hugely".
"Now these people have a chance at life. They can look forward to their children going back to school in September after having Spinraza, with a chance to live, a chance to look forward. It's just an amazing day.
"Somebody said it was like winning the Lotto, it’s even better than that," he said.
Irish office of Biogen which produces #Spinrata has thanked the HSE for "continuing to negotiate" to find a solution for future patients diagnosed with Spinal Muscular Atrophy— Ailbhe Conneely (@AilbheConneely) June 11, 2019
Muscular Dystrophy Ireland Chief Executive Elaine McDonnell said: "Spinraza has the potential to be life-changing for children and their families.
"Those who have already been treated with Spinraza have seen improvements that were previously never thought possible, and now all children in Ireland who need this innovative treatment can be given the same chance."