Biopharmaceutical company UCB has announced that it has received a final appraisal determination from the National Institute for Healthcare Excellence (NICE), recommending Fintepla (fenfluramine). The treatment will be available as an add-on therapy for patients aged two year and above.
Fintepla is an oral solution developed to treat seizures associated with Dravet syndrome, a rare, lifelong form of epilepsy that begins in infancy. The condition affects around one in every 15,000 people in the UK.
The condition is marked by severe refractory seizures – seizures that are not brought under control by medicine – frequent medical emergencies, significant cognitive and behavioural impairments, and a significantly increased risk of sudden unexpected death in epilepsy (SUDEP).
Claire Brading, managing director, UK and Ireland, UCB, said: “Given that Dravet syndrome is particularly challenging to treat, we are acutely aware of the ongoing unmet medical need for people living with this condition. This news underscores the wider recognition of addressing this unmet need and echoes UCB’s ongoing commitment to the epilepsy community.
“We are delighted to have received this positive NICE decision and look forward to making this treatment option more widely available as an add-on therapy for Dravet syndrome patients in the UK.”
NICE based its decision on phase 3 study data that showed Fintepla effectively reduced the frequency of convulsive seizures for Dravet syndrome patients, whose seizures were not controlled on existing medications.