FDA approves supplemental NDA for Aptiom (eslicarbazepine acetate) monotherapy to treat partial onset seizures- Sunovion + Eisai

Sunovion Pharma announced that the FDA approved the supplemental NDA for Aptiom (eslicarbazepine acetate) monotherapy for the treatment of partial onset seizures. This new approval allows Aptiom to be used as a monotherapy in people who initiate treatment for the first time or convert from other anti-epileptic drugs. Previously approved in 2013 as adjunctive therapy for partial onset seizures, Aptiom is the only exclusively once daily non-extended release anti-epileptic drug which can be used alone or in combination in the treatment of partial onset seizures. Approval was supported by two Phase III trials (studies 093-045 and 093-046).

Comment: With more convenient dosing and a purported improved safety profile over Trileptal and Tegretol, Aptiom (eslicarbazepine acetate, formerly Stedesa) is forecast to become the best-selling pipeline antiepileptic drug. Factoring in monotherapy approval and first-line use, epilepsy-specific sales are forecast to top $400 million across the seven major markets by 2019.

Comment: Eslicarbazapine acetate was approved in Europe on 21 April 2009 as Zebinix and is marketed by Eisai.