The European Commission (EC) has approved Zogenix’s Fintepla (fenfluramine) for the treatment of seizures associated with Dravet syndrome.
The oral solution is indicated as an add-on therapy to other anti-epileptic medicines for patients two years of age and older.
The approval is based on positive safety and efficacy results from two phase III trials, as well as data from an interim analysis of a long-term extension study in 330 Dravet syndrome patients treated up to three years.
In these studies, it was found that Fintepla, when added to other antiepileptic therapies, provided a highly statistically significant and clinically meaningful reduction in convulsive seizure frequency.
The most commonly reported side effects included decreased appetite, diarrhoea, pyrexia, fatigue, upper respiratory tract infection, lethargy, somnolence and bronchitis.
“We deeply appreciate the physicians and Dravet community whose support led to this important milestone,” said Stephen Farr, president and chief executive officer of Zogenix.
“With the EC approval in place, we can now begin making Fintepla more widely available for the treatment of Dravet syndrome patients in Europe who seek new safe and effective treatment options,” he added.
Dravet syndrome is a rare and life-long form of epilepsy that typically begins in infancy and is characterised by frequent, treatment-resistance seizures, as well as significant developmental, motor and behavioural impairments.
Fintepla was also approved by the US Food and Drug Administration (FDA) for the treatment of Dravet syndrome-associated seizures earlier this year.