Aptiom is a once-daily oral drug containing eslicarbazepine acetate, a third-generation member of the commonly prescribed first-line dibenzazepine family of anti-epileptic drugs (AEDs), including carbamazepine (first-generation) and oxcarbazepine (second-generation). When in the body, eslicarbazepine acetate is cleaved to the active ingredient eslicarbazepine, which is also an active metabolite of oxcarbazepine. Eslicarbazepine exerts an anti-epileptic effect by competitively interacting with the inactivated state of voltage-gated sodium channels, effectively reducing the transmission of seizure signals, as well as blocking channels involved in nociceptive pain.
In November 2009, Eisai launched Zebinix (Aptiom’s EU trade name) in the UK for the adjunctive therapy of adult epilepsy patients with POS, with or without secondary generalization; this was followed by subsequent launches in other EU countries.In December 2016, the European Commission extended the marketing authorization for Zebinix to cover patients aged six years and below. In May 2016, the European Medicines Agency (EMA) accepted Bial’s application to review data supporting Zebinix’s monotherapy use in adults with newly diagnosed partial-onset epilepsy. Since this time, the Committee for Medicinal Products for Human Use has adopted a positive opinion and has recommended the addition of monotherapy use to the terms of marketing authorization, and Datamonitor Healthcare expects an approval decision by May 2017.
Aptiom has also achieved regulatory approval in a range of other markets including in the US, where its label has been expanded to include monotherapy. Sumitomo Dainippon is currently awaiting regulatory decisions in the US regarding expansion of Aptiom’s indications for adjunctive therapy and monotherapy to include treatment of POS in children aged four years and below. Plans for a Phase III clinical trial in children younger than four years also suggest that Sumitomo Dainippon may attempt to expand Aptiom’s label further to include younger children.
TABLE OF CONTENTS
4 Product Profiles
4 Aptiom : Epilepsy
LIST OF FIGURES
19 Figure 1: Aptiom for epilepsy – SWOT analysis
21 Figure 4: Darzalex sales for multiple myeloma across the US, Japan, and five major EU markets, by country, 2015–24
LIST OF TABLES
5 Table 1: Aptiom epilepsy indication approvals
6 Table 2: Aptiom drug profile
8 Table 3: Aptiom pivotal trial data in epilepsy
15 Table 4: Ongoing late-phase trials
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