Zogenix Announces Receipt of FDA Breakthrough Therapy Designation for ZX008 in Dravet Syndrome
FDA Breakthrough Therapy Designation is intended to expedite the development and review of medicines aimed at treating a serious or life-threatening disease where there is preliminary clinical evidence that the investigational therapy may offer substantial improvement over existing therapies on at least one clinically significant endpoint. FDA Breakthrough Therapy Designation for ZX008 is based on the results from Study 1, Zogenix’s first global Phase 3 trial of ZX008, which met the primary efficacy endpoint, as well as all prespecified key secondary efficacy endpoints.
“We are very pleased that the
ZX008 is designated as an orphan drug in both the U.S. and
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Source: Zogenix, Inc.