Zogenix Receives Orphan Drug Designation for FINTEPLA® (Fenfluramine) in Japan
Zogenixplans to submit a new drug application (J-NDA) for FINTEPLA in Japanfor the treatment of seizures associated with Dravet syndrome by year end.
- Dravet syndrome is a rare, life-long form of epilepsy marked by severe seizures, significant developmental delays, frequent hospitalizations and medical emergencies, and increased risk of premature death.
- Seizures associated with Dravet syndrome are highly resistant to existing anti-epileptic medicines, pointing to a major need for new treatment options.
Dravet syndrome is a rare infant- and childhood-onset epilepsy marked by frequent and severe treatment-resistant seizures, associated hospitalizations and medical emergencies, significant developmental and motor impairments, and an increased risk of sudden premature death.
The MHLW accreditation of Orphan Drug Designation follows the Japanese Pharmaceutical Affairs & Food Sanitation Council’s (PAFSC)
“The orphan drug designation of FINTEPLA in
The incidence of Dravet syndrome in
About Dravet Syndrome
Dravet syndrome is a rare, devastating and life-long form of epilepsy that generally begins in infancy and is marked by frequent, treatment-resistant seizures, significant developmental, motor, and behavioral impairments, and an increased risk of sudden unexpected death in epilepsy (SUDEP). Affecting one in 15,700 live births in the U.S. and approximately one in 20,000 to 40,000 live births in Europe, most patients follow a course of developmental delay with cognitive, motor and behavioral deficits that persist into adulthood. Dravet syndrome severely impacts quality of life for patients, families and caregivers due to the high physical, emotional, caregiving, and financial burden associated with the disease.
FINTEPLA is a prescription medicine used to treat the seizures associated with Dravet syndrome in patients 2 years of age and older. FINTEPLA possesses dual activities to inhibit seizures: as a serotonergic agent, acting as a potent 5-HT releaser with agonist activity at 5-HT1D, 2A, and 2C receptors, and as a positive modulator of Sigma1R. Fenfluramine is approved in the
Across multiple clinical studies, FINTEPLA demonstrated significant and sustained reduction of convulsive seizures associated with Dravet syndrome. In two pivotal Phase 3 trials, the reduction in convulsive seizure frequency per 28 days was statistically significantly greater for all dose groups of FINTEPLA compared to placebo. Please see important FINTEPLA prescribing and safety information at www.fintepla.com.
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed,” and similar expressions are intended to identify forward-looking statements. These statements include plans to submit a J-NDA for FINTEPLA in
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Source: Zogenix, Inc