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Sunovion Pharmaceuticals Inc. (Sunovion) announced that the U.S. Food and Drug Administration (FDA) 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 impact on development and poor prognosis frequently associated with schizophrenia that begins in adolescence underscores the need for treatment that is both well-tolerated and effective,” said Robert Findling, M.D., M.B.A., Vice President of Psychiatric Services and Research at the Kennedy Krieger Institute, Director of Child and Adolescent Psychiatry at the Johns Hopkins University School of Medicine and a study investigator. “The availability of LATUDA provides healthcare providers with an important new option for helping adolescents with this illness that is chronic and severely disabling.”
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.
“We are pleased that LATUDA’s range of indications has now expanded beyond the adult population to include the treatment of schizophrenia in adolescents aged 13 to 17 years. We believe that LATUDA, as the first such medication in five years approved for adolescent patients with schizophrenia, is an important new treatment option for this difficult to treat illness,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “This approval builds on and reflects our commitment to advancing the treatment of serious psychiatric illness.”
