Zogenix, Inc. (NASDAQ:ZGNX) announced last month that it received a Committee for Medicinal Products for Human Use (CHMP) recommending marketing approval for FINTEPLA as a treatment for dravet syndrome.
Dravet syndrome is a rare type of epilepsy that is common in infants. Zogenix has been developing as a potential add-on treatment for dravet syndrome. It is therefore supposed to be combined with other therapies used to treat or provide relief to epileptic patients. CHMP is a division of the European Medicines Agency (EMA). The positive opinion means that it has recommended that FINTEPLA should receive marketing authorization for the indicated use.
“We are pleased that the CHMP’s regulatory review of FINTEPLA for quality, safety, and efficacy has resulted in their positive opinion,” stated Zogenix CEO, Dr. Stephen J. Farr.
Dr. Farr also revealed in his statement that Zogenix commenced FINTEPLA’s global development program almost 6 years ago. They started after Belgian researchers discovered fenfluramine can provide seizure relief in patients that suffer from dravet syndrome. Most of the patients that suffer from this disease experience severe and frequent seizures even when regularly taking available anti-seizure medication. FINTEPLA is thus an exciting addition for seizure patients because it will improve the treatment options, while crucially the frequency of seizures.
FINTEPLA’s MMA was backed by favorable clinical trial data
FINTEPLA’s Marketing Authorization Application (MAA) contained the positive findings of the treatment’s Phase 3 trials. It also included data from an ongoing interim analysis that is an open-label study evaluating 330 patients diagnosed with dravet syndrome. The studies have so far demonstrated that fenfluramine’s ability to significantly reduce the occurrence of convulsive seizures, especially when compared to a placebo.
The clinical trial findings also indicate that the treatment is well tolerated by patients. The long-term study has so far demonstrated a robust efficacy profile. There were however some adverse effects observed, such as bronchitis, somnolence, lethargy, upper respiratory tract infection, fatigue, and diarrhea. If FINTEPLA receives approval from the European Commission, it will be marketed as a dravet syndrome treatment that can be administered to children above 2-years-old in EU member states, Norway, Iceland, Liechtenstein, and the UK.