NICE gives green light to fenfluramine

Posted 30th May 2022 in News

Today’s announcement from NICE (The National Institute for Health and Care Excellence), recommending the use of fenfluramine to treat Dravet Syndrome, a rare and life-limiting form of epilepsy, has been welcomed by national charity Dravet Syndrome UK.

In a Final Appraisal Document (FAD), fenfluramine is recommended as an add-on to other antiepileptic medicines for treating seizures associated with Dravet syndrome in people aged 2 years and older. 

Dravet Syndrome occurs in around 1 in every 15,000 live births in the UK. As one of the most treatment-resistant epilepsies, it severely affects the health and quality of life of patients, and has a huge impact on carers and their families. Children and adults with Dravet Syndrome experience multiple and prolonged seizures. Seizures can be life-threatening with an overall higher mortality rate than seen in other epilepsies. The condition also encompasses learning disability, neurodevelopmental and mobility issues, and other related conditions, which may be worsened through uncontrolled seizures.

“Dravet Syndrome is a catastrophic condition which has a devastating impact on every aspect of life”, says Galia Wilson, Chair and Trustee of Dravet Syndrome UK, whose son has Dravet Syndrome. “Individuals with the condition and their families are in urgent need of improved treatments and care. Dravet Syndrome can be unpredictable so, like many of the current treatments, fenfluramine may not work for all, but we know from clinical and real-life experience that it can be transformative. We’re delighted that this decision will give families in England and Wales the opportunity to see if fenfluramine works for them.”

Also welcoming today’s announcement is Professor Helen Cross, President of the ILAE (International League Against Epilepsy) and Chair of Dravet Syndrome UK’s Medical Advisory Board: “A key goal in the treatment of Dravet Syndrome is to safely reduce the number of seizures that contribute to poor long term neurodevelopmental outcomes and higher mortality risk. Clinical evidence shows that fenfluramine has the potential to dramatically reduce seizures in a large percentage of patients, leading to improved seizure control and potential for better overall outcomes. We’re extremely pleased that NICE has recognised this today, and that fenfluramine will shortly be made available to UK patients.”

Dravet Syndrome UK was consulted by NICE (along with other clinical experts and organisations) during their review of fenfluramine. Galia Wilson added: “We would like to thank NICE for their consideration in listening to the patient and carer community during this process, particularly with regard to impact on quality of life.”

Fenfluramine was first developed as an anti-obesity medication. It was withdrawn in 1997 due to cardiovascular side effects. When researchers discovered that lower doses of fenfluramine may show benefit in patients with drug-resistant epilepsy, this prompted a new phase of scientific research. Low dose fenfluramine was developed by Zogenix International* specifically for use in Dravet Syndrome and has now been studied in over 700 patients with Dravet Syndrome in international clinical trials.1 In these trials, fenfluramine was generally well tolerated and has not been associated with an increased risk of cardiovascular side effects. (*Zogenix is now part of UCB, following an acquisition announced in March 2022).

Following today’s FAD, the final technology appraisal guidance for fenfluramine in England and Wales is expected to be published by NICE on 6th July 2022. An application to the Scottish Medicines Consortium for use of fenfluramine in patients with Dravet Syndrome is planned for 2022.

The announcement comes in the run up to Dravet Syndrome Awareness Month in June, when Dravet Syndrome UK will be running a social media campaign to raise awareness of this devastating condition. The charity hopes that greater awareness will lead to more individuals receiving an early diagnosis, so they can get access to treatment, therapies and support that they need.

For more information about Dravet Syndrome, see

You can read the FAD in full here


  1. 1. H. Cross et al. Impact of fenfluramine on the expected SUDEP mortality rates in patients with Dravet Syndrome. Seizure. 2021 Dec; 93:154-159