Zogenix gets EU marketing authorisation for anti-seizure drug
pharmafile | December 23, 2020 | News story | Research and Development |
The European Commission (EC) has granted marketing authorisation for Zogenix’s FINTEPLA (fenfluramine), an oral solution for the treatment of seizures associated with Dravet syndrome, as an add-on therapy to other anti-epileptic medicines for patients two years of age and older.
Dravet syndrome is a rare, lifelong epilepsy that begins in infancy and is marked by severe refractory seizures, frequent medical emergencies, significant cognitive and behavioural impairments, and an increased risk of sudden premature death.
The EC’s approval of FINTEPLA was based on positive safety and efficacy results from two randomised, international, multi-centre, placebo-controlled Phase III trials, as well as data from an interim analysis of a long-term, open-label extension study in 330 Dravet syndrome patients treated up to three years.
When added to other anti-epileptic treatments, FINTEPLA provided a highly statistically significant and clinically meaningful reduction in convulsive seizure frequency. The most commonly reported adverse events that occurred in patients receiving this treatment included decreased appetite, diarrhoea, pyrexia, fatigue, upper respiratory tract infection, lethargy, somnolence, and bronchitis.
With the EC’s approval, and subject to price and reimbursement being implemented according to national regulations, Zogenix will be able to market FINTEPLA in all European Union member countries, as well as in the United Kingdom, Norway, Iceland, and Liechtenstein.
Dr Tilman Polster, a Paediatric Epilepsy Specialist at the Mara Hospital of the Bethel Epilepsy Centre in Germany, and primary investigator for fenfluramine oral solution in Dravet syndrome, said: “After a healthy start in life, children with Dravet syndrome suffer from frequent and prolonged epileptic seizures, which determine the future of the child and mean that parents are on constant alert. Current treatments for Dravet syndrome are unsatisfactory, resulting in the disease affecting motor and mental development.
“Experience from clinical studies has shown that FINTEPLA offers an impressive reduction in seizures, plus an improvement in quality of life. In conjunction with the ongoing data being collected on the safety profile of the therapy, FINTEPLA represents an effective new treatment option and an important hope for the families concerned.”
Darcy Jimenez
