Zogenix Gets FDA Priority Review of Fintepla for Seizures in Lennox-Gastaut Syndrome
01 Dezembro 2021 - 10:57AM
Dow Jones News
By Colin Kellaher
Zogenix Inc. on Wednesday said the U.S. Food and Drug
Administration granted priority review to its application for
expanded use of Fintepla for the treatment of seizures associated
with Lennox-Gastaut syndrome, a rare childhood-onset epilepsy.
The Emeryville, Calif., pharmaceutical company said the
application is based on a Phase 3 study that showed Fintepla was
superior to placebo in reducing the frequency of drop seizures,
along with long-term safety and effectiveness data from its ongoing
open-label extension trials.
The FDA grants priority review to medicines that have the
potential to provide significant improvements in the treatment of a
serious disease, and the designation shortens the review period.
Zogenix said the agency set a target action date of March 25, 2022,
for its application.
The FDA last year approved Fintepla for the treatment of
seizures associated with Dravet syndrome, another rare
childhood-onset epilepsy, in patients two years of age and
older.
Shares of Zogenix, which closed Tuesday at $11.25, rose 7.3% in
premarket trading Wednesday.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 01, 2021 08:42 ET (13:42 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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