6 March 2018  - Sunovion Pharmaceuticals today announced that the U.S. FDA approved a supplemental new drug application that expands the use of Latuda (lurasidone hydrochloride) to include the treatment of major depressive episode associated with bipolar I disorder (bipolar depression) in paediatric patients (10 to 17 years of age).

Latuda is also approved in the U.S. for the treatment of adults with bipolar depression as monotherapy and adjunctive therapy with lithium or valproate, and for the treatment of adolescents (13 to 17 years of age) and adults with schizophrenia.

The approval for the expanded indication of Latuda was supported by data from a Phase 3 clinical study of children and adolescents (10 to 17 years of age) with bipolar depression. In this study, Latuda was associated with statistically significant and clinically meaningful improvement in bipolar depression symptoms compared to placebo and was generally well-tolerated.

Read Sunovion Pharmaceuticals press release