Eisai’s Banzel is an oral sodium channel modulator which is structurally different from currently approved anticonvulsants on account of its triazole derivative structure. The drug’s sole approved indication is the adjunctive treatment of seizures associated with LGS in adults and children aged one year and older. LGS is a severe form of epilepsy, which constitutes 3–10% of childhood epilepsies (Abu Saleh and Stephen, 2008).
Banzel was discovered and developed by Novartis and was acquired by Eisai in February 2004 (Eisai, 2004). Eisai gained EU approval for Banzel in January 2007 and first launched the drug for the management of LGS under its European brand name Inovelon in Germany in June 2007 (Eisai, 2007).
The US Food and Drug Administration (FDA) approved Banzel for the adjunctive treatment of LGS in November 2008 and the drug was launched in January 2009 (Eisai, 2008). In March 2013, Eisai also received manufacturing and marketing authorization from the Ministry of Health, Labour and Welfare in Japan, where the drug will be marketed as Inovelon (Eisai, 2013). Inovelon has been designated as an orphan drug in Japan since June 2011.
Banzel (rufinamide; Eisai) currently possesses the narrowest approved indication of the key marketed anticonvulsants. Lennox-Gastaut syndrome (LGS) is considered to be one of the most severe of the childhood epilepsy syndromes, and despite the small patient population there is a high unmet need associated with the condition. Within its approved indication of LGS, Banzel faces strong competition from more established brands such as Lamictal (lamotrigine; GlaxoSmithKline), Topamax (topiramate; Johnson & Johnson/Kyowa Hakko Kirin), and Onfi (clobazam; Lundbeck), which benefit from more extensive physician familiarity. With Eisai having launched Banzel for the treatment of LGS in several geographical regions, and with no known plans to expand into additional indications, Datamonitor Healthcare believes that Banzel’s uptake will remain limited.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Banzel : Epilepsy
LIST OF FIGURES
7 Figure 1: Banzel for epilepsy – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary for Banzel in epilepsy
9 Figure 3: Datamonitor Healthcare’s drug assessment summary for Banzel in epilepsy
LIST OF TABLES
4 Table 1: Banzel drug profile
6 Table 2: Banzel pivotal trial data in epilepsy
7 Table 3: Safety profile for Banzel in epilepsy
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