Approvals

UCB’s Fintepla (fenfluramine) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged two years and older.

The health technology assessment agency has recommended in final draft guidance that the drug, which is the first non-cannabis based treatment to be approved for the severe form of epilepsy, be given alongside other anti-seizure medicines.

Approximately 60,000 children in England are affected by epilepsy, with LGS accounting for up to 2% of cases. LGS is highly resistant to many anti-epileptic drugs and is characterised by frequent and unpredictable seizures that can lead to cognitive issues, difficulties with mobility, as well as an increased risk of injury. Administered orally every day, Fintepla is designed to increase the levels of serotonin in the brain to help to reduce seizure activity.

NICE’s decision was supported by phase 3 trial results demonstrating that Fintepla reduced the frequency of drop seizures, which cause a loss of consciousness and muscle control, by 26.5% on average compared with a 7.6% reduction for placebo.

Stephen Powis, national medical director for NHS England said: “For children and families living with LGS, every day can be challenging, facing unpredictable and life-limiting seizures, and this new treatment option on the NHS will now offer new hope, giving many the chance for greater stability and a better quality of life.

“To have a proven, evidence-based new medicine that can be taken at home to help control and reduce their child’s seizures… is fantastic news for hundreds of families.”