Developed to treat adult patients with major depressive episodes associated with bipolar I disorder, Latuda has been approved for use as monotherapy and as adjunctive therapy with either lithium or valproate.
Dainippon Sumitomo Pharma representative director, president and chief executive officer Masayo Tada said the company looks to build on the strong foundation started in the US to bring Latuda to other markets around the world.
"In addition, we are preparing for Phase 3 clinical trials for bipolar I disorder (bipolar depression) in Japan, an important market for us, where Phase 3 clinical trials for schizophrenia are already underway," Tada added.
The approval was based on the data from two positive double-blind trials that evaluated two new indications for Latuda for the treatment of adult patients with bipolar depression.
Image: Latuda is the first atypical antipsychotic indicated for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) both as monotherapy and as adjunctive therapy with either lithium or valproate. Photo: Business Wire.