Zogenix’s FINTEPLA® (Fenfluramine) Oral Solution Now Available in Germany for the Treatment of Seizures in Dravet Syndrome
Zogenix announced the availability of FINTEPLA (fenfluramine) oral solution in Germany for treating seizures associated with Dravet syndrome, a severe epilepsy affecting infants. Approved by the European Commission in December 2020, FINTEPLA can be prescribed as an add-on therapy for patients aged two and older. The treatment aims to reduce convulsive seizure frequency in patients not adequately controlled by existing medications. Safety studies showed significant seizure reductions but noted common side effects such as decreased appetite and diarrhea.
- FINTEPLA is now available in Germany, providing a new treatment option.
- European Commission approval received in December 2020 based on positive Phase 3 study results.
- Common adverse events reported include decreased appetite, diarrhea, and fatigue, which could affect patient adherence.
- Potential risks related to valvular heart disease and pulmonary arterial hypertension may limit commercialization.
- FINTEPLA offers a new treatment option for patients in Germany with Dravet syndrome, a rare, devastating, infant-onset epilepsy marked by frequent seizures, medical emergencies, and developmental impairments
- FINTEPLA was approved by the European Commission in December 2020 based on data from two Phase 3 studies demonstrating it safely and significantly reduced convulsive seizure frequency for Dravet syndrome patients whose seizures were not adequately controlled on their existing medications
EMERYVILLE, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies, announced today that FINTEPLA® (fenfluramine) oral solution is now available in Germany for the treatment of seizures associated with Dravet syndrome in patients aged two years and older, as an add-on therapy to existing anti-epileptic medications. Dravet syndrome is a rare, lifelong epilepsy that begins in infancy and is marked by severe refractory seizures, frequent medical emergencies, significant cognitive and behavioral impairments, and an increased risk of sudden premature death (SUDEP).
“Patients with Dravet syndrome experience severe and often prolonged seizures that are highly resistant to existing anti-convulsant medications. Despite treatment with one or more of the currently available medications, most patients’ seizures are not adequately controlled,” said Dr. Jens Grünert, Medical Director, Zogenix Germany. “With the launch of FINTEPLA in Germany, physicians and caregivers here can now access an urgently needed, effective and generally well-tolerated new treatment option to help reach their goals of reducing the devastating seizures and improving outcomes and quality of life for patients and their families.”
FINTEPLA will be available in Germany starting on 1 February 2021 under a controlled access program requested by the European Medicines Agency. In Germany, physicians will register for an identification number before being able to prescribe FINTEPLA via the following website: www.fenfluramin-wichtige-infos.de/verschreiber. Further details regarding prescribing and patient monitoring requirements can be found on the European Medicines Agency website: https://www.ema.europa.eu/en/medicines/human/EPAR/fintepla.
The approval of FINTEPLA by the European Commission in December 2020 was based on positive safety and efficacy results from two randomized, international, multi-center, placebo-controlled Phase 3 trials (Study 1 and Study 2), as well as data from an interim analysis of a long-term, open-label extension study in 330 Dravet syndrome patients treated up to 3 years. In the studies, most patients given FINTEPLA in addition to their existing regimen of antiepileptic therapies, experienced a statistically significant and clinically meaningful reduction in convulsive seizure frequency. The most commonly reported adverse events that occurred in patients included decreased appetite, diarrhea, pyrexia, fatigue, upper respiratory tract infection, lethargy, somnolence and bronchitis.
About FINTEPLA®
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, which corroborated the statistically significant and clinically meaningful convulsive seizure reductions seen in earlier multinational Phase 3 studies. FINTEPLA is also being studied for the potential treatment of seizures associated with other rare epilepsies.
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.
About Zogenix
Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company’s first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare epilepsy, and one for MT1621, an investigational therapy for the treatment of a rare genetic disorder called TK2 deficiency (being developed through its subsidiary Modis Therapeutics). Zogenix is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for genetic rare epilepsies.
Forward-Looking Statement
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 the potential that fenfluramine oral solution will be an important new treatment option for Dravet syndrome patients and Zogenix’s plans to commercialize fenfluramine in Europe. These statements are based on Zogenix’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: Zogenix’s ability to successfully launch FINTEPLA, including launching a controlled access program implemented due to risks related to valvular heart disease and pulmonary arterial hypertension; the COVID-19 pandemic may disrupt Zogenix’s business operations, impairing the ability to commercialize FINTEPLA in Europe and Zogenix’s ability to generate product revenue in Europe; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA in Europe; unexpected adverse side effects or inadequate therapeutic efficacy of fenfluramine that could limit commercialization, or that could result in recalls or product liability claims; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the U.S. 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 undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
CONTACTS:
Zogenix
Melinda Baker
Senior Director, Corporate Communications
+1 (510) 788-8732 | corpcomms@zogenix.com
Investors
Brian Ritchie
Managing Director, LifeSci Advisors LLC
+1 (212) 915-2578 | britchie@lifesciadvisors.com
Media
In Europe: Kerry Lloyd-Jones, Account Director, Porter Novelli
+44 (0) 7949 794 290 | kerry.lloyd-jones@porternovelli.co.uk
In the US: Stefanie Tuck, Vice President, Porter Novelli
+1 (978) 390-1394 | stefanie.tuck@porternovelli.com
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