July 24th, 2018

// Zogenix is set to become a key player in the epilepsy market following positive results for ZX008, says GlobalData

Zogenix is set to become a key player in the epilepsy market following positive results for ZX008, says GlobalData

Zogenix’s positive results for its drug ZX008 (fenfluramine hydrochloride) and the subsequent approval that is likely to follow, will push Zogenix to become a key player in the epilepsy market, according to GlobalData, a leading data and analytics company.

Zogenix will treat young children and adolescents suffering from Dravet syndrome. The results will allow Zogenix to push ahead with its plan to submit regulatory filings in the US and EU markets in Q4 2018, swiftly following GW Pharmaceutical’s Epidiolex (cannabidiol).

GlobalData’s report: ‘PharmaPoint: Epilepsy – Global Drug Forecast and Analysis to 2026’, highlights that Dravet syndrome is a rare form of pediatric epilepsy that has proved difficult to treat, with current therapies showing poor efficacy, safety, or tolerability profiles. As such, treatments for this form of epilepsy are one of the more significant needs in the epilepsy market.

Rahael Maladwala, Pharma Analyst at GlobalData, comments: “Moving forward, the company has stated that it expects to file a regulatory submission in the US and EU by the end of the year, with a view to launch by the end of 2019.

“However, with trials also running in patients suffering from Lennox-Gastaut syndrome (LGS) and the epilepsy market lacking effective therapies, it is likely that Zogenix will continue to file for approval in other epilepsy patient populations after Dravet syndrome.”

The timing of ZX008’s approval will likely elicit competition with GW Pharmaceutical’s Epidiolex, which was approved by the FDA last month for the treatment of Dravet syndrome and LGS patients. While Epidiolex has already been approved in the US, the molecule has a controversial mechanism of action, as it is a pure extract from cannabis. Consequently, Epidiolex has to overcome further regulatory hurdles set by the Drug Enforcement Agency (DEA), which will delay its launch.

Maladwala adds: “ZX008 has already been used in a compassion program in Belgium, and therefore has proven efficacy in a real-world setting, which may sway the decision of some physicians. Realistically, the high unmet need for effective treatments in pediatric epilepsies such as Dravet syndrome and LGS mean that both drugs will likely experience a quick uptake and command a large market share in these patient populations.

“All that remains to be seen now is whether or not the company can formulate an effective marketing strategy as well as a favorable pricing and reimbursement position that will maximize sales of ZX008 and encourage its uptake over Epidiolex.”

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