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     151  0 Kommentare Zogenix Launches Global Access Program for FINTEPLA (Fenfluramine) Oral Solution

    • FINTEPLA is approved in the U.S. and European Union as an add-on therapy for the treatment of seizures associated with Dravet syndrome in patients aged two years and older.
    • The new program supports physician access to FINTEPLA in other parts of the world, where local regulations allow, including European countries where reimbursement has not yet been established.

    EMERYVILLE, Calif., April 27, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced the launch of its new global access program for FINTEPLA (fenfluramine) oral solution. FINTEPLA was approved in the U.S. and European Union in 2020 as an add-on therapy for the treatment of seizures associated with a debilitating rare epilepsy called Dravet syndrome in patients aged two years and older. The Zogenix Access Program expands access for physicians in other parts of the world, where local regulations allow, including European countries where reimbursement has not yet been established.

    “Three randomized clinical studies have demonstrated FINTEPLA's ability to provide transformational and durable seizure reduction for many Dravet syndrome patients whose seizures were not adequately controlled despite treatment with one or more other anti-epileptic medicines,” said Bradley S. Galer, M.D., Executive Vice President and Chief Medical Officer at Zogenix. “With these results and more than one thousand treated Dravet syndrome patients, physicians in many countries have expressed interest in FINTEPLA for their patients. We are pleased to be able to take this step to support their requests and help more patients in need.”

    Zogenix has partnered with Durbin, a part of Uniphar Group’s Product Access Division and a leading specialist in the international distribution of specialized pharmaceuticals, to manage the Zogenix Access Program for FINTEPLA. Durbin has extensive global experience providing, high-quality support while adhering to complex local requirements.

    “We are delighted to be working in partnership with Zogenix on this important access program,” said Dan Piggott, Managing Director of Uniphar Group’s Product Access Division. “We look forward to helping facilitate broader access to FINTEPLA for patients with critical unmet medical needs.”

    About the Zogenix Access Program
    The Zogenix Access Program is for physicians who are interested in treating their patients with FINTEPLA in countries where it is not yet available commercially or through local access schemes. The program does not provide free-of-charge access to FINTEPLA and does not affect patients already taking FINTEPLA as part of a clinical study. Specifics of the program may vary by country based on local regulations.

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    Zogenix Launches Global Access Program for FINTEPLA (Fenfluramine) Oral Solution FINTEPLA is approved in the U.S. and European Union as an add-on therapy for the treatment of seizures associated with Dravet syndrome in patients aged two years and older.The new program supports physician access to FINTEPLA in other parts of the …