Zogenix Launches Global Access Program for FINTEPLA (Fenfluramine) Oral Solution - Seite 2

In the U.S. and Europe, treatment with FINTEPLA is initiated and supervised by physicians with experience in the treatment of epilepsy under a Risk Evaluation Mitigation Strategy (REMS) program (U.S.) or Controlled Access Program (EU). Similarly, access through this program must be requested by the patient’s treating physician. Where local regulations allow, an initial registration process enables the program team to begin working with physicians on treatment and important safeguard planning.

Physicians can learn more about the Zogenix Access Program for FINTEPLA by sending an email inquiry to [e-mail].

About FINTEPLA
Fintepla is a new treatment option that in clinical studies provided significant, well-tolerated, and lasting seizure reduction to many Dravet syndrome study patients. In 2020, FINTEPLA (fenfluramine) oral solution was approved by the U.S. Food & Drug Administration (FDA) and by the European Commission as an add on therapy to other anti-epileptic medicines for the treatment of seizures associated with Dravet syndrome in patients aged two years and older. In addition, Zogenix recently reported positive results of a third Phase 3 study of FINTEPLA in Dravet syndrome to support planned registration in Japan, a study that corroborated the statistically significant and clinically meaningful convulsive seizure reductions seen in earlier multi-national Phase 3 studies. FINTEPLA is also being studied for the potential treatment of seizures associated with other rare epilepsies.

In the United States, please see important prescribing and safety information at www.Fintepla.com. In Europe, please see important prescribing and safety information at www.Fintepla.eu.

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.