The U.S. Food and Drug Administration granted expanded approval to Sunovion Pharmaceuticals Inc.'s Latuda to treat major depressive episode associated with bipolar I disorder in children.
Bipolar disorder is a chronic mental health condition that can affect individuals of all ages and is characterized by potentially debilitating severe mood swings, including periods of depression and mania.
Latuda is also approved in the U.S. to treat adults with bipolar depression as monotherapy and as therapy given in addition to lithium or valproate. It is also approved to treat adolescents and adults with schizophrenia.
The expanded approval of Latuda was supported by data from a phase 3 trial of children and adolescents with bipolar I disorder, where Latuda showed an improvement in bipolar depression symptoms compared to placebo.
Bipolar disorder affects about 12.6 million adults in the U.S. About 50% to 66% of adults with bipolar disorder experience their first symptoms before age 18, according to the Massachusetts-based biopharmaceutical company.
The disorder affects about 1.7% of children in the U.S., but that number could be even higher as bipolar disorder is often misdiagnosed, Sunovion said.
Sunovion is an indirect subsidiary of Japan-based Sumitomo Dainippon Pharma Co. Ltd.
