FDA Approves FINTEPLA (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome
- FINTEPLA??significantly and substantially reduced convulsive seizure frequency in patients whose seizures were not adequately controlled on other medications, as observed in two phase 3 placebo-controlled clinical trials
- Commercial launch planned for?July 2020
- Zogenix?to host an investor call tomorrow,?June 26, at?8:30 AM ET?/?5:30 AM PT
Friday, June 26, at?8:30 AM Eastern Time?/?5:30 AM Pacific Time |
Toll Free:? 877-407-9716 |
International:? 201-493-6779 |
Conference ID:?13706215 |
Webcast:??http://public.viavid.com/index.php?id=140519 |
- There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension.
- Echocardiogram assessments are required before, during, and after treatment with FINTEPLA.
- FINTEPLA is available only through a restricted program called the FINTEPLA REMS.