FDA thumbs up for Latuda in adolescents with schizophrenia

The US Food and Drug Administration has approved the supplemental New Drug Application (sNDA) for Latuda (lurasidone HCI) for the treatment of schizophrenia in adolescents aged 13 to 17 years, says the drug’s maker Sunovion, a US subsidiary of Japanese pharma company Sumitomo Dainippon (TYO: 4506).

Latuda is also approved in the USA 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.

This is the first treatment approved in five years for adolescents aged 13-17 years with schizophrenia, the company noted.