Sunovion’s Pediatric Epilepsy Pill Receives FDA Approval
NEC member Sunovion Pharmaceuticals recently received approval from the Food and Drug Administration (FDA) for its anti-epilepsy drug, Aptiom, to treat children and adolescents.
Sunovion’s supplemental New Drug Application (sNDA) was approved for its once-a-day Aptiom pill to help patients under the age of 18 manage their partial-onset seizures. Data from three clinical trials was used to determine the safety of the pill for pediatric patients and the suggested dosage. Although partial-onset seizures are the most common type of seizures, there are few medical options for children that provide reliable relief for patients and their families.
“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.”
The New England Council commends Sunovion’s dedication to helping all patients manage their symptoms in a safe and effective manner. Read more in Business Wire.