Zogenix Seeks Marketing Approval of Fintepla for Seizures in Japan
The company’s new drug application will be reviewed and decided on by the Japanese Ministry of Health, Labour, and Welfare.
“There remains a substantial unmet need in the Dravet syndrome treatment landscape globally, and Japan is no exception where patients continue to experience refractory seizures that negatively impact quality of life,” Stephen J. Farr, PhD, president and CEO of Zogenix, said in a press release.
Fintepla is a low-dose oral fenfluramine solution used to inhibit seizure activity in those with Dravet who are 2 years or older.
It works by affecting the signaling of serotonin — a potent neurotransmitter which helps transmit messages between cells in the brain. The medication also affects sigma receptors, a type of cell membrane receptor commonly found in nerve cells.
Additionally, it had received orphan drug designation — a designation for medications designed to treat rare diseases, allowing for government assistance — from the Japanese ministry in August last year.
This new drug application in Japan was supported by results of a multi-national, placebo-controlled Phase 3 study (NCT02826863) involving 143 Dravet patients, age 2 to 18, whose seizures were not controlled by existing anti-epileptic medicines (refractory).
After a six-week observation period before the trial, patients were randomly assigned to receive 0.7 or 0.2 milligrams per kilogram per day (mg/kg/day) of Fintepla, or a placebo, in addition to each patient’s current anti-epileptic medications. Doses were increased to reach target dosages over two weeks and remained at the fixed dosage for 12 weeks.
The trial met its primary goal in demonstrating that those who received the 0.7 mg/kg/day dose achieved a 64.8% reduction in the average number of monthly convulsive seizures compared to those given the placebo.
The medication was well-tolerated, with adverse events similar to those seen in previous Phase 3 clinical trials.
These multiple studies have shown that treatment with Fintepla leads to a significant and sustained reduction in convulsive seizures associated with Dravet syndrome.
If approved in Japan, Fintepla will be commercialized through Zogenix’s exclusive agreement with Nippon Shinyako, a Japanese pharmaceutical product developer and distributor.
Zogenix will retain responsibility for completing its global clinical development programs and seeking regulatory approval for Fintepla in Japan for both Dravet and Lennox Gastaut syndromes.
“We are committed to advancing FINTEPLA as a potential treatment option to ensure that patients in Japan living with this rare, highly refractory form of childhood-onset epilepsy have access to this therapy,” Farr said.