Posted by Michael Wonder on 30 Aug 2015
Sunovion announces FDA approval of a new indication for Aptiom (eslicarbazepine acetate) as monotherapy for partial-onset seizures
28 August 2015 - Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) approved 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.
“We are pleased to have achieved FDA approval of a monotherapy indication for Aptiom, based on the results of two identically designed Phase 3 clinical studies conducted by Sunovion. Data from the monotherapy trials, in addition to the data generated from the adjunctive trials, confirm that Aptiom is efficacious and well-tolerated as adjunctive or monotherapy treatment within a daily dose range of 800 to 1,600 milligrams. Prescribers now have greater flexibility to optimize clinical response and tolerability when using APTIOM to treat people with partial-onset seizures,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer, Sunovion Pharmaceuticals Inc., and Head of Global Clinical Development for Sumitomo Dainippon Pharma Group.
For more details, go to: http://www.sunovion.com/news/pressReleases/20150828.pdf
