FDA to review Aptiom for children who experience seizures

The FDA decision could come up with a decision as soon as Sept. 13 under the Prescription Drug User Fee Act. | File photo

The U.S. Food and Drug Administration will evaluate a drug that could help treat children who suffer from seizures. 

Aptiom is said to offer a vital monotherapy and adjunctive therapy options for young children who suffer from partial-onset seizures. The FDA is reviewing the medicine, for children 4 to 17, according to Sunovion Pharmaceuticals, Inc. It could come up with a decision as soon as Sept. 13 under the Prescription Drug User Fee Act.

“We are pleased that the FDA has accepted our supplemental New Drug Application to potentially bring a new treatment option to children and adolescents who experience partial-onset seizures,” Dr. Anthony Loebel, Sunovion's executive vice president and chief medical officer, said. “We look forward to working closely with the FDA as we seek to bring APTIOM to young people with epilepsy who experience partial-onset seizures.”

The daily medicine is featured as the only one of its kind as an antiepileptic drug.

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Organizations in this story

Sunovion Pharmaceuticals Inc. 84 Waterford Dr Marlboro, MA 01752