Zogenix Seeks FDA Expanded OK of Fintepla in Lennox-Gastaut Syndrome
28 Septiembre 2021 - 8:18AM
Noticias Dow Jones
By Colin Kellaher
Zogenix Inc. on Tuesday said it filed with the U.S. Food and
Drug Administration for expanded approval of Fintepla for the
treatment of seizures associated with Lennox-Gastaut syndrome.
The Emeryville, Calif., pharmaceutical company said the filing
is supported by data from a Phase 3 study that showed Fintepla was
superior to placebo in reducing the frequency of drop seizures in
patients with the severe, rare form of epilepsy that isn't
well-controlled by currently available anti-seizure
medications.
The FDA last year approved Fintepla for the treatment of
seizures associated with Dravet syndrome, a rare childhood-onset
epilepsy, in patients two years of age and older.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 28, 2021 09:03 ET (13:03 GMT)
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