New indication for Sunovion's Aptiom approved by US FDA

USA-based Sunovion Pharmaceuticals, a subsidiary of Japanese pharma major Sumitomo Dainippon Pharma (TYO; 4506), has received approval from the US Food and Drug Administration for the supplemental New Drug Application (sNDA) for Aptiom (eslicarbazepine acetate) as monotherapy for the treatment of partial-onset seizures.

This new approved indication allows Aptiom to be used as monotherapy in people who initiate treatment for the first time or convert from other antiepileptic drugs (AEDs) to Aptiom. Previously approved in 2013 by the FDA as adjunctive therapy for partial-onset seizures, Aptiom is the only exclusively once-daily non-extended release AED, which can be used alone or in combination with other AEDs in the treatment of partial-onset seizures.

Offer greater patient flexibility