Zogenix Gets FDA Priority Review of Fintepla for Seizures in Lennox-Gastaut Syndrome

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)

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