Fintepla
Authorised
This medicine is authorised for use in the European Union
fenfluramine
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Fintepla is a medicine used in addition to other epilepsy medicines to treat patients from 2 years of age who have Dravet syndrome or Lennox-Gastaut syndrome, types of epilepsy that begin in childhood and continue into adulthood.
These conditions are rare, and Fintepla was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the Agency’s website (Dravet syndrome: 18 December 2013; Lennox-Gastaut syndrome: 27 February 2017).
Fintepla contains the active substance fenfluramine.
The medicine can only be obtained by ‘special’ prescription. This means that it is used under stricter conditions than normal to prevent misuse and to ensure doctors are informed about the need for regular heart checks in patients taking the medicine. Treatment should be started and supervised by a doctor experienced in the treatment of epilepsy.
Fintepla is available as a liquid to be taken by mouth twice a day. The dose depends on the patient’s weight and, for Dravet syndrome, whether the patient is taking another epilepsy medicine called stiripentol. The dose can be adjusted based on the response to treatment.
For more information about using Fintepla, see the package leaflet or contact your doctor or pharmacist.
The active substance in Fintepla, fenfluramine, causes the release of serotonin in the brain. Serotonin is a substance used by nerve cells to communicate with neighbouring cells. The exact way that fenfluramine works is not fully understood. It is thought that serotonin acts on several targets in the brain to improve symptoms of patients with Dravet syndrome or Lennox-Gastaut syndrome. Fenfluramine may also protect against seizures by acting on the sigma-1 receptor found on the surface of nerve cells.
Studies showed that Fintepla reduces the frequency of seizures in children and young adults with Dravet syndrome or Lennox-Gastaut syndrome who are taking at least one other epilepsy medicine.
Two main studies involving a total of 205 patients with Dravet syndrome compared Fintepla with placebo (a dummy treatment), both given in addition to the patient’s standard of care.
In the first study, the average (median) monthly number of seizures reduced from 21 to 5 in patients treated with Fintepla, and from 34 to 26 in those taking placebo. The study also showed that 73% of patients treated with Fintepla and 10% of those taking placebo had at least a 50% reduction in the monthly number of seizures.
In the second study, patients were also taking stiripentol and at least one other epilepsy medicine. The average (median) monthly number of seizures reduced from 14 to 4 in patients treated with Fintepla and remained at 11 in patients taking placebo. In this study, 55% of patients treated with Fintepla and 9% of those taking placebo had at least a 50% reduction in the monthly number of seizures.
A third main study involving 263 patients with Lennox-Gastaut syndrome compared Fintepla with placebo, both given in addition to the patient’s standard of care. The main measure of effectiveness was the change in the frequency of drop seizures (brief loss of muscle tone and reduced consciousness, causing abrupt falls). The study found that the average (median) frequency of drop seizures reduced by 26.5% in the 87 patients receiving Fintepla compared with 7.6% in those receiving placebo (87 patients). The study also showed that the monthly number of drop seizures fell by at least half in 25% of patients treated with Fintepla and 10% of those taking placebo.
In patients with Lennox-Gastaut syndrome, the most common side effects with Fintepla (which may affect more than 1 in 10 people) are decreased appetite, tiredness, somnolence (sleepiness), vomiting and diarrhoea.
In patients with Dravet syndrome, the most common side effects with Fintepla are decreased appetite, diarrhoea, fever, tiredness, upper respiratory tract infection (nose and throat infection), lethargy (lack of energy), somnolence and bronchitis (chest infection).
For the full list of side effects of Fintepla, see the package leaflet.
Fintepla must not be taken by patients who have heart or lung problems called valvular heart disease or pulmonary hypertension. It must also not be used by patients who have used medicines called monoamine oxidase inhibitors (MAOI), including MAOI antidepressants, in the last 2 weeks.
For the full list of restrictions, see the package leaflet.
Dravet syndrome and Lennox-Gastaut syndrome are rare diseases with limited treatment options. Fintepla used in addition to other epilepsy medicines has been shown to reduce the frequency of seizures in children and young adults with these diseases. The side effects are considered manageable with the measures described below in place to prevent the risks.
The European Medicines Agency therefore decided that Fintepla’s benefits are greater than its risks and it can be authorised for use in the EU.
Serious cases of heart and lung problems (valvular heart disease and pulmonary arterial hypertension) have been reported with higher doses of the medicine used in the past for the treatment of obesity in adults. Although these effects have not been reported at the lower doses used in patients with Dravet syndrome or Lennox-Gastaut syndrome, several measures have been put in place to minimise this risk:
- The company that markets Fintepla will ensure that a system is put in place to control access to the medicine and prevent misuse. Doctors who are expected to prescribe this medicine will receive educational material with information about monitoring patients’ heart function and minimising misuse of the medicine.
- The company that markets Fintepla will also provide doctors with educational materials to give to patients to inform them about the need for heart monitoring and how to detect and manage heart and lung problems, should they occur.
- The company will set up a registry to collect data on the long-term safety of Fintepla and to assess whether the measures to minimise the risk of serious side effects have worked.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fintepla have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Fintepla are continuously monitored. Side effects reported with Fintepla are carefully evaluated and any necessary action taken to protect patients.
Fintepla received a marketing authorisation valid throughout the EU on 18 December 2020.
Product information
Latest procedure affecting product information:
VR/0000268730
02/05/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Fintepla
- Active substance
- Fenfluramine hydrochloride
- International non-proprietary name (INN) or common name
- fenfluramine
- Therapeutic area (MeSH)
- Epilepsies, Myoclonic
- Anatomical therapeutic chemical (ATC) code
- N03
Pharmacotherapeutic group
AntiepilepticsTherapeutic indication
Treatment of seizures associated with Dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older.
Fintepla is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.
News on Fintepla
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