Sunovion's Aptiom Receives FDA Approval for Expanded Indication

Sunovion today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) to expand the indication for its antiepileptic drug (AED) Aptiom (eslicarbazepine acetate) to include treatment of partial-onset seizures (POS) in children and adolescents four to 17 years of age.

Aptiom is also approved in the U.S. for the treatment of POS in adults. Aptiom is a once-daily, immediate release AED that can be taken whole or crushed, with or without food.

“Despite being the most common seizure type in patients with epilepsy, there continues to be a critical need for new therapeutic options for partial-onset seizures, especially for children and adolescents,” said Steven Wolf, M.D., Director of Pediatric Epilepsy and Associate Professor of Neurology at Mount Sinai Health System. “The unpredictable nature of seizures can be disruptive in the lives of these young people and their families, friends and community. It is important that physicians have additional treatment options that address patient needs.”

The approval to expand Aptiom’s indication to include children four years of age and older is based on FDA guidance that permits the extrapolation of data to support pediatric use. The safety and efficacy of Aptiom as monotherapy and adjunctive therapy for the treatment of POS in adults was established in five multicenter, randomized, controlled clinical trials. Data from three clinical trials conducted by Sunovion’s partner BIAL also supported the safety and tolerability of Aptiom for the treatment of POS in pediatric patients. Pharmacokinetic analyses of adult and pediatric data supported the proposed dosing regimen in the pediatric population.

“Epilepsy can be a challenging condition to manage. An estimated one in three people living with epilepsy are unable to control their seizures through available treatments,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “Treatment decisions must be based on individual needs, and we are pleased to offer Aptiom to people, including children and adolescents, who may need a once-daily treatment option for partial-onset seizures that can be taken whole or crushed, with or without food.”

“We are pleased that the benefits of treatment with Aptiom for children and adolescents four years of age and older with partial-onset seizures have now been established,” said David Frawley, Executive Vice President and Chief Commercial Officer at Sunovion. “This approval further emphasizes Sunovion’s commitment to people living with epilepsy and to advancing the treatment of partial-onset seizures.”