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Zogenix announced the US Food & Drug Administration has granted its investigational drug, ZX008, orphan drug designation for the treatment of Lennox Gastaut Syndrome.
Zogenix (NASDAQ:ZGNX) announced the US Food & Drug Administration has granted its investigational drug, ZX008, orphan drug designation for the treatment of Lennox Gastaut Syndrome.
As quoted in the press release:
The Orphan Drug Designation by the FDA follows the European Union’s granting of Orphan Drug Designation for ZX008 in the treatment of LGS earlier this year.
“The receipt of Orphan Drug Designation in the treatment of LGS represents another significant milestone for our ZX008 development program,” said Stephen J. Farr, Ph.D., President and Chief Executive Officer of Zogenix. “The Investigational New Drug (IND) Application for our Phase 3 LGS study was approved to proceed by the FDA in April. We intend to initiate this clinical trial in the second half of 2017, following the availability of top-line Phase 3 data in our initial indication, Dravet syndrome. We expect that the first patients will enroll in the planned LGS study in the fourth quarter of 2017.”
Click here to read the full press release.
Source: globenewswire.com
