US FDA backs news indications for Latuda; grants Priority Review for Perjeta

Sunovion Pharmaceuticals, a US subsidiary of Japan’s Dainippon Sumitomo Pharma (TYO: 4506), says that the US Food and Drug Administration has approved two new indications for the use of its Latuda (lurasidone HCl), namely as monotherapy and adjunctive therapy with either lithium or valproate, both to treat adult patients with major depressive episodes associated with bipolar I disorder (bipolar depression).

“These two approvals represent a significant milestone not only for Sunovion and DSP, but for the millions of Americans who are living with bipolar disorder and struggling to manage the symptoms of bipolar depression,” said Masayo Tada, representative director, president and chief executive of Dainippon Sumitomo, adding: “We look forward to building on the strong foundation started in the United States to bring Latuda to other markets around the world. In addition, we are preparing for Phase III clinical trials for bipolar I disorder (bipolar depression) in Japan, an important market for us, where Phase III clinical trials for schizophrenia are already underway. This is part of Sunovion and DSP’s ongoing commitment to researching, developing and commercializing new treatments for people with mental illness.”

“Patients with bipolar disorder spend the majority of their symptomatic time in the depressed phase of the illness. This phase most commonly results in impaired function, a remarkable decrease in quality of life and may lead to increased risk for attempted suicide,” said Joseph Calabrese, Professor of Psychiatry and director of the Mood Disorders Program at University Hospitals Case Medical Center, Case Western Reserve University. “Unfortunately, there are very few treatments specifically approved to treat the symptoms of bipolar depression, which represents a very large unmet medical need for patients and their families,” he noted.