Zogenix (ZGNX)

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On April 8, 2019, Zogenix, Inc. (the “Company”), announced that it received a Refusal to File (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”) regarding its New Drug Application (“NDA”) for FINTEPLA (ZX0008, fenfluramine hydrochloride) for the treatment of seizures associated with Dravet syndrome. Upon its preliminary review, the FDA determined that the NDA, submitted on February 5, 2019, was not sufficiently complete to permit a substantive review. In the letter, the FDA cited two reasons for the RTF decision: first, certain non-clinical studies were not submitted to allow assessment of the chronic administration of fenfluramine; and, second, the application contained an incorrect version of a clinical dataset, which prevented the completion of the review process that is necessary to support the filing of the NDA. The FDA has not requested or recommended additional clinical efficacy or safety studies.

The Company will seek immediate guidance, including a Type A meeting with the FDA, to clarify and respond to the issues identified in the RTF letter in order to re-file the NDA.

The Company’s Marketing Authorization Application (“MAA”) for FINTEPLA for the treatment of seizures associated with Dravet syndrome was previously accepted for review by the European Medicines Agency (“EMA”), and the Company anticipates an approvability decision could be reached by the EMA in the first quarter of 2020.



ZGNX 35.50 16.50 (-31.82%)