•FINTEPLA® (fenfluramine) has been approved in Ireland for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), as an add on therapy to other anti-epileptic medicines in patients two years of age and older
• This treatment for DS and LGS, which are rare epilepsies, will be available for patients in Ireland from January 2025, around one year ahead of the anticipated approval date
Slough (United Kingdom), 20th December 2024 – UCB is pleased to announce that the Health Service Executive (HSE) has approved FINTEPLA® (fenfluramine) for the treatment of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients from two years of age.1,2 This reimbursement has allowed eligible patients to access fenfluramine much sooner than expected under the routine approval processes.
Nadeem Aurangzeb, Head of Rare & Epilepsy, UCB UK & Ireland, said: “We are immensely pleased that fenfluramine has been approved by the HSE. We know that Irish patients and their families have been looking forward to accessing this treatment, due to the burden that Dravet syndrome and Lennox Gastaut syndrome places on the lives of those living with these complex, rare conditions. We’re also pleased that Irish patients will be able to access fenfluramine over a year ahead of the expected approval date. This approval means fenfluramine is available to Irish patients ahead of those in the rest of the UK, which is almost unheard of.”
LGS is a rare, severe, early-onset developmental epileptic encephalopathy, which is characterised by multiple types of seizures, intellectual impairment and electroencephalography (EEG) abnormalities.3 It affects around 0.1 to 0.28 people per 100,000 and it accounts for 1-10% of childhood epilepsies and 1-2% of all epilepsies.3
The approval of fenfluramine for the treatment of LGS-associated seizures is based on phase 3 data and a long-term open-label extension study.4,5 In the phase 3 trial, 263 patients ages two to 35 years were randomised to receive either fenfluramine or placebo. Patients assigned to fenfluramine experienced a significantly greater reduction in drop seizures, compared with the placebo group. The most frequent adverse events included decreased appetite, somnolence, and fatigue, and there were no cases of valvular heart disease (VHD) or pulmonary arterial hypertension (PAH).4 Furthermore, in the open-label extension study, patients taking fenfluramine continued to experience sustained (39.4% 51.8%, 28.6% overall) reductions in drop seizure frequency.5 The treatment was generally well-tolerated and long-term VHD and PAH was not observed.5
DS, another developmental epileptic encephalopathy, is also a rare and life-long form of epilepsy that begins in infancy and is marked by frequent seizures.6,7 People living with DS experience significant developmental and motor impairments that persist into adulthood and quality of life is severely impacted for patients, their families, and caregivers due to its high physical, emotional, and financial burden.8,9
Data from a randomised, double-blind, placebo-controlled phase 3 trial supports the use of fenfluramine in DS, where 119 patients received either fenfluramine or placebo.10 Fenfluramine provided significantly greater reduction in convulsive seizure frequency, compared with the placebo group. It was also generally well-tolerated, with no observed cases of VHD or PAH.
People living with both LGS and DS have an increased risk of sudden death, known as Sudden Unexpected Death (SUDEP), and it is estimated that there are over 130 epilepsy-related deaths in Ireland per year.11,12,13
Nicola Kehoe of Dravet Syndrome Ireland said: “We are delighted to have fenfluramine available as a funded treatment for people living with Dravet syndrome and Lennox Gastaut Syndrome in Ireland. We know from the international community that fenfluramine is very effective in reducing seizures and we welcome the potential improvements in health and quality of life for our community of families living with these very complex epilepsies.”
Fenfluramine is currently only available to people living with LGS in Ireland, however, UCB is working collaboratively to secure reimbursement for patients living in England, Wales and Scotland. Marketing authorisation was previously obtained from the European Medicines Agency (EMA) in 2020, and approval was obtained from the European Commission (EC) in 2023.1 The Medicines and Healthcare products Regulatory Agency (MHRA) authorised fenfluramine for the treatment of seizures associated with DS and LGS in July 2023.14
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For further information, contact UCB:
Karen Borrer, Communications Lead, UCB UK & Ireland
T: +44 (0) 7775 003538
E: karen.borrer@ucb.com
References can be shared on request at robynmaginnis@ipn.ie
