The European Commission has approved the use of a new drug as an add-on therapy for the treatment of Dravet Syndrome in patients 2 years and older.
The Commission’s approval of FINTEPLA (Fenfluramine) will mean that the drug’s manufacturers can now apply to European member states regulatory authorities to make the drug available and/or reimbursed in that country.
Dravet Syndrome is a rare and severe form of childhood-onset epilepsy which is refractory in nature – meaning that it is extremely difficult to treat.
We welcome the EU Commission’s approval of the drug for treatment in Dravet syndrome. Families who are caring for someone with a diagnosis of Dravet`Syndrome are desperate to see more treatments available – something we highlighted in our recent submission supporting the reimbursement of Epidyolex in Ireland. You can read more on that this by reading the associated article about this submission in the 'News' section of our website.
Fenfluramine was originally developed as an appetite suppressant but was removed from the market after some patients experienced cardiac and pulmonary side effects. As a result, it will be available under a controlled access program. The manufacturers will also maintain a Fintepla Registry to provide data on its long-term safety.
The drug was approved following clinical trials which found that fenfluramine provided a significantly greater reduction in convulsive seizure frequency compared with placebo and was generally well tolerated, with no observed cardiac or pulmonary effects. You can read more about these trials by visiting the Lancet medical journal's website.
We have reached out to the drug’s manufacturers seeking an update on their plans with regard to availability and reimbursement in Ireland. As soon as we have an update, we will update our website and social media channels.
You can read more about FINTEPLA by visiting the European Medicines Agency website.