Givinostat decision for Duchenne patients
Deputy O'Rourke calls for a rapid decision on givinostat for children with Duchenne muscular dystrophy, saying every day matters. The Tánaiste says the process should move efficiently and he will convey the Deputy’s concerns to the Minister.
Givinostat is a potentially life-altering drug for children with Duchenne muscular dystrophy. The European Commission granted conditional marketing authorisation for givinostat almost a year ago, on 6 June 2025. There has been a frustrating delay, some of it on the company's behalf. I understand that the HSE's drugs group will review givinostat at its June meeting and make a recommendation to the senior leadership team to approve the medicine or not. There is a campaign, Time is Muscle. Every day counts for these children. I ask that a decision be made as early as possible. Children need access to this drug.
Comment on this
I thank Deputy O'Rourke for highlighting this issue. I also wish to acknowledge the point that he made the point that sometimes delays can be on the side of the company. That is an important point of balance to make.
I do not actually have the detail in relation to this but it is important that everybody in the process work in an efficient way so that we at least get a decision and clarity as early as possible. The drugs budget is growing in this country, and quite rightly. I am sure this is a very anxious time for the families impacted and I will certainly convey the Deputy's views to the Minister for Health.