- In Epilepsy and behavior editorial, the authors write that the FINTEPLA data demonstrate “an unprecedented level of seizure control” for treated patients living with Dravet syndrome, a severe and debilitating epilepsy of childhood.
- The authors also recognize FINTEPLA for obtaining clinically important results in outcomes reported by caregivers, such as quality of life for patients and their families.
EMERYVILLE, Calif., July 21, 2021 (GLOBE NEWSWIRE) – Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company that develops and markets therapies for rare diseases, has announced that its product FINTEPLA® (fenfluramine) oral solution has been recognized by two prominent clinicians in a Epilepsy and behavior editorial titled “Raising the bar: Fenfluramine sets new treatment standards for Dravet syndrome. “
In the editorial, the authors, Joseph Sullivan, MD, of UCSF Benioff Children’s Hospitals, and Helen Cross, MB, Ch.B. Ph.D., from the UCL Institute of Child Health in the UK, notes that the treatment and diagnosis of severe and rare epilepsies such as Dravet syndrome has improved in the US and Europe with accurate diagnosis earlier (genetic tests), better access to a network of specialized medical care and the availability of new drugs. In particular, they note that FINTEPLA achieved response rates for seizure reduction at the> / = 75% level that were previously only observed at the> / = 50% level. In their review, the authors write that future treatments for Dravet syndrome “should be evaluated against the demonstrated efficacy of fenfluramine”.
“Our primary goal in treating patients with Dravet syndrome is to safely reduce the number and severity of seizures that contribute to poor long-term neurodevelopmental outcomes and a higher risk of death,” said the Dr Sullivan. “With the availability of more approved treatment options and the significant levels of seizure reduction seen with fenfluramine, we now have additional tools to achieve profound seizure reduction, better neurodevelopmental outcomes, and improved quality of life for a patient. large percentage of our patients. “
FINTEPLA was approved in the United States and the European Union in 2020 for the treatment of seizures associated with patients with Dravet syndrome aged two years and older. The authors write that the new results reported with the FINTEPLA treatment, such as the effects on executive functions, have effectively raised the bar for the evaluation of future therapies. Their opinion is based on the body of previously published data from clinical trials that supported US and EU regulatory reviews, as well as data from patients treated for up to three years in an ongoing open label study. and in early access programs. In all studies, the data demonstrate that FINTEPLA provides safe, effective and long-lasting seizure reduction for the majority of patients treated with Dravet syndrome, including those who, prior to FINTEPLA treatment, continued to experience seizure load high despite treatment with one or more other antiepileptic drugs.
In all studies, FINTEPLA was generally well tolerated, no cases of pulmonary arterial hypertension (PAH) or valvular heart disease (VHD) were observed. The most common adverse events were reported as decreased appetite, fatigue, diarrhea and pyrexia.
Please see important prescribing and safety information for FINTEPLA at www.fintepla.com.
“Through our years of partnering with physician and caregiver communities, we have come to know the dramatic unmet needs that Dravet syndrome patients and their families face every day,” said Bradley S. Galer, MD, medical director of Zogenix. “We are delighted that these experts saw the tremendous benefits of fenfluramine as a new treatment option for physicians, patients and families, and see it as a standard against which new treatments should be evaluated. Zogenix remains committed to continuing to study the potential of fenfluramine to help more patients and families living with rare epileptic conditions.
* The editorial will appear in the August 2021 issue of Epilepsy & Behavior and is available online now for registered users. [Joseph Sullivan, J. Helen Cross, Raising the bar: Fenfluramine sets new treatment standards for Dravet syndrome, Epilepsy & Behavior, Volume 121, Part A, 2021,108061,ISSN 1525-5050 (https://doi.org/10.1016/j.yebeh.2021.108061 or https://www.sciencedirect.com/science/article/pii/S152550502100295X)]
About Dravet syndrome
Dravet syndrome is a rare, devastating, and lifelong form of epilepsy that usually begins in early childhood and is characterized by frequent, treatment-resistant seizures, significant developmental, motor and behavioral disturbances, and risk increased sudden unexpected death in epilepsy (SUDEP). Affecting one in 15,700 live births in the United States and about one in 20,000 to 40,000 live births in Europe, most patients present with developmental delay with cognitive, motor and behavioral deficits that persist into adulthood. Dravet syndrome severely affects the quality of life of patients, families and caregivers due to the high physical, emotional, caring and financial burden associated with the disease.
Zogenix is a global biopharmaceutical company engaged in the development and commercialization of therapies with the potential to transform the lives of patients and their families living with rare diseases. The Company’s First Rare Disease Treatment, FINTEPLA® (fenfluramine) oral solution, has been approved by the US FDA and the European Medicines Agency and is under development in Japan for the treatment of seizures associated with Dravet syndrome, a rare and serious lifelong epilepsy. The company has two additional late stage development programs: one in a rare epilepsy called Lennox-Gastaut syndrome and one in a mitochondrial disease called TK2 deficiency. Zogenix also plans to initiate a study of FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is working with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.
Zogenix cautions you that statements included in this press release that are not descriptions of historical fact are forward-looking statements. Words such as “believes”, “anticipates”, “plans”, “expects”, “indicates”, “will”, “intention”, “potential”, “suggests”, “assuming”, “Designed” and similar expressions are intended to identify forward-looking statements. These statements include the potential that fenfluramine oral solution could be an important new treatment option for patients with Dravet syndrome; Zogenix’s plans to market fenfluramine in Europe and Zogenix’s plans for its development programs. These statements are based on Zogenix’s current beliefs and expectations. The inclusion of forward-looking statements should not be taken as a representation by Zogenix that any of its plans will be realized. Actual results may differ from those presented in this press release due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: FINTEPLA may not be widely accepted by the market as a treatment option for Dravet syndrome, which would limit the ability of the company to generate general revenue; Zogenix’s ability to successfully launch FINTEPLA, including the launch of a controlled access program implemented due to the risks associated with valve disease and pulmonary arterial hypertension; the COVID-19 pandemic may disrupt Zogenix’s business operations, hampering the ability to market FINTEPLA in Europe and Zogenix’s ability to generate product revenue in Europe; Zogenix may fail to execute its sales and marketing strategy for the commercialization of FINTEPLA in Europe; unexpected adverse side effects or inadequate therapeutic efficacy of fenfluramine which could limit the marketing, or which could lead to recalls or product liability claims; and other risks described in previous Zogenix press releases as well as in periodic public filings with the United States Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix makes no commitment to revise or update this press release to reflect any events or circumstances. subsequent to the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This warning is made under the Safe Harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
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