FDA gives supplemental approval for Latuda (lurasidone HCI) for the treatment of schizophrenia in adolescents aged 13 to 17 years- Sunovion Pharma

Sunovion Pharmaceuticals has announced that the FDA has approved the supplemental New Drug Application (sNDA) for Latuda (lurasidone HCI) for the treatment of schizophrenia in adolescents aged 13 to 17 years. Latuda is also approved in the U.S. for the treatment of adults with schizophrenia and for the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

The approval is based on results from a randomized, double-blind, placebo-controlled, six-week study in which adolescent patients with schizophrenia received fixed doses of Latuda 40 mg/day, Latuda 80 mg/day or placebo. At study endpoint, LATUDA 40 mg/day and 80 mg/day were associated with statistical and clinical improvement in symptoms of schizophrenia compared to placebo. Latuda was also generally well tolerated with limited effects on weight and metabolic parameters.