Briviact (brivaracetam; UCB) is a follow-on product to Keppra (levetiracetam; UCB/Otsuka), acting as an anticonvulsant by binding to the synaptic vesicle glycoprotein 2A (SV2A), directly causing decreased neurotransmitter release. Structurally, it is related to Keppra, but Briviact possesses a binding affinity to SV2A that is ten times greater than that of levetiracetam. Briviact is also a modest inhibitor of sodium channels.
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) approved Briviact (brivaracetam; UCB) for the adjunctive treatment of patients with partial-onset seizures in early 2016. The drug’s clinical program has incorporated a wide range of doses (5–200mg), with consistent efficacy finally established at the top of this dose range. While the approval of Briviact provides UCB with an opportunity to reduce its sales reliance on Keppra (levetiracetam; UCB/Otsuka), the company’s former leading epilepsy brand that has gone now generic, none of the Phase III trials have provided an indication as to how Briviact differentiates itself from Keppra. In addition, UCB has been focusing its attention on the development of its other epilepsy brand Vimpat (lacosamide). Datamonitor Healthcare believes that UCB will continue to focus on increasing Vimpat’s indication coverage, leaving further clinical development of Briviact until after Vimpat has gained a broad label. In the short term, this will be to Briviact’s detriment, as without the increased patient population acquired through indication expansions, it is unlikely that Briviact will have a profound impact on the market.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Briviact : Epilepsy
LIST OF FIGURES
10 Figure 1: Briviact for epilepsy – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary for Briviact in epilepsy
12 Figure 3: Datamonitor Healthcare’s drug assessment summary for Briviact in epilepsy
LIST OF TABLES
4 Table 1: Briviact drug profile
6 Table 2: Briviact pivotal trial data in epilepsy
8 Table 3: Most common adverse events in Phase III IV Briviact study
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