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On 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Fintepla1, intended for the treatment of seizures associated with Dravet syndrome.

The applicant for this medicinal product is Zogenix ROI Limited.

Fintepla will be available as an oral solution (2.2 mg/ml). The active substance of Fintepla is fenfluramine, an antiepileptic. The precise mechanism of action is not known. Fenfluramine acts to release 5-HT (serotonin) and so increase stimulation of some brain 5-HT receptors, as well as acts on the sigma-1 receptor.

The benefits of Fintepla lie in its ability to help manage the seizures associated with Dravet syndrome. The most common side effects are decreased appetite, diarrhoea, pyrexia, fatigue, upper respiratory tract infection, lethargy, somnolence and bronchitis. Because of known risk of valvular heart disease and pulmonary arterial hypertension, though associated with higher doses of fenfluramine than those used for Dravet syndrome, echocardiography monitoring program is mandatory.

The full indication is:

Fintepla is indicated for the treatment of seizures associated with Dravet syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

Fintepla should be initiated and supervised by physicians experienced in the treatment of epilepsy. It should be prescribed and dispensed according to a controlled access programme.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

1 This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained.

Key facts

Agency product number
International non-proprietary name (INN) or common name
  • fenfluramine
Active substance
  • Fenfluramine hydrochloride
Therapeutic area
Epilepsies, Myoclonic

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
Company name
Zogenix ROI Limited
Application type
Initial authorisation

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