The FDA recently rejected a marketing application for Zogenix’s Fintepla, an anti-epileptic drug candidate for Dravet syndrome. Magdalene Crabbe, Neurology and Ophthalmology Analyst at GlobalData, a leading data and analytics company, discusses the revelation:
“The impact of this setback is not necessarily catastrophic. Fintepla is still at the pre-registration stage in the EU and in Japan and a deal where Zogenix provided Japanese pharmaceutical company Nippon Shinyaku with the exclusive distribution rights to Fintepla, indicates that there is still hope for the clinical and commercial prospects of this promising drug candidate.
“According to GlobalData, forecasted sales of Fintepla would reach $872m in 2026 in the seven major markets (7MM*), positioning Fintepla as the second-highest selling drug in the epilepsy market behind GW Pharmaceuticals’ Epidiolex. The pipeline for Dravet syndrome consists of 22 products, nine of which are currently in ongoing clinical trials.
“Zogenix does have some time to re-attempt an application as there are few products in late-stage development for Dravet syndrome and Fintepla is currently the frontrunner in terms of having been given breakthrough designation by the FDA.
“However, Fintepla is at risk of losing a critical share of the market if this delay allows other pipeline products to gain approval before the matter is finally resolved. Right now, Zogenix should prioritise their meetings with the FDA in order to get the materials together to submit an application that will be approved so Fintepla can progress to the next stage.”
*7MM: US, France, Germany, Italy, Spain, UK and Japan