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FDA Approves Latuda (lurasidone HCl) for Bipolar Depression in Pediatric Patients (10 to 17 Years of Age)

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- March 6, 2018 -- Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) that expands the use of Latuda (lurasidone HCI) to include the treatment of major depressive episode associated with bipolar I disorder (bipolar depression) in pediatric 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.

“Bipolar disorder is a leading cause of disease burden in the pediatric population both here in the U.S. and across the globe, but unfortunately, few treatments are effective in treating young people living with the condition,” said Robert Findling, M.D., M.B.A., Vice President of Psychiatric Services and Research at the Kennedy Krieger Institute, Director, Child & Adolescent Psychiatry at the Johns Hopkins University School of Medicine. “We know that children who have been diagnosed with bipolar depression can be at risk for poor school performance and impairments in social functioning. The FDA approval of this medicine for the treatment of pediatric patients with bipolar depression is significant for several reasons. First, it is a new treatment option for this vulnerable group of young people. Also, it is the first single-agent formulation to receive regulatory approval for this pediatric indication.”

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.

“With limited approved treatment options for these patients, the FDA approval of Latuda marks an important milestone for the mental health community,” said David Frawley, Executive Vice President, Chief Commercial Officer at Sunovion. “We are proud to build on the strong foundation of Latuda for adults with bipolar depression and to now be able to offer this medicine as a treatment option for pediatric patients living with this devastating condition.”

Phase 3 Study Results

In the six-week, randomized, double-blind, placebo-controlled study, 347 children and adolescents (10 to 17 years of age) with bipolar depression received once-daily Latuda flexibly dosed (20-80 mg/day) or placebo. Latuda was associated with statistically significant and clinically meaningful improvement in bipolar depression symptoms compared to placebo, based on the primary efficacy endpoint of change from baseline to Week 6 on the Children’s Depression Rating Scale, Revised (CDRS-R) total score (-21.0 vs. -15.3; effect size = 0.45, p<0.0001). Statistically significant and clinically relevant change from baseline to Week 6 on the Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) at the secondary endpoint was also seen with Latuda compared to placebo (-1.49 vs. -1.05; effect size = 0.44, p<0.0001).

Latuda was generally well-tolerated. The most common treatment-emergent adverse events (TEAEs) reported for Latuda compared to placebo were nausea (16.0% vs. 5.8%), weight gain (6.9% vs. 1.7%) and insomnia (5.1% vs. 2.3%).

About Bipolar Disorder

Bipolar disorder is a chronic mental health condition that can affect individuals of all ages and is characterized by potentially debilitating severe mood swings, including periods of depression and mania.1,2 It affects approximately 12.6 million adults in the U.S.3,4 Approximately 50 to 66 percent of adults with bipolar disorder experience their first symptoms before age 18, and it can be difficult to diagnose.5,6,7 Bipolar disorder affects approximately 1.7 percent of the pediatric population in the U.S.8 But, that number could be even higher as bipolar disorder is often misdiagnosed.9,10 Symptoms of bipolar disorder can be severe and may result in thoughts about death or suicide during depressive episodes.11

Bipolar disorder is the fourth leading cause of disease burden among children and adolescents worldwide.12 Bipolar I disorder is characterized by at least one lifetime manic or mixed episode; individuals often have one or more depressive episodes.13 Bipolar depression refers to the depressive phase of bipolar disorder;1 its symptoms include: depressed mood, loss of interest or pleasure in activities, significant weight loss, insomnia, fatigue, feelings of worthlessness, diminished ability to concentrate and recurrent thoughts of death or suicide attempt.1 When symptomatic, depressive symptoms affect patients more commonly than manic symptoms.14 Bipolar disorder has been shown to result in significant impairment in work, family and social function,15,16 and is associated with increased direct and indirect health care costs.17

About Latuda

Latuda is a prescription medicine used:

  • To treat adults and adolescents (13 to 17 years of age) with schizophrenia
  • Alone to treat adults, children and teenagers (10 to 17 years of age) with depressive episodes that happen with bipolar I disorder (bipolar depression)
  • With the medicine lithium or valproate to treat adults with depressive episodes that happen with bipolar I disorder (bipolar depression)

Latuda is available in five tablet strengths: 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.

The effectiveness of Latuda for longer-term use, that is, for more than six weeks, has not been established in controlled studies. Therefore, the physician who elects to use Latuda for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. The efficacy of Latuda in the treatment of mania associated with bipolar disorder has not been established.

About Sunovion Pharmaceuticals Inc. (Sunovion)

Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s vision is to lead the way to a healthier world. The company’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions.

Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company’s websites:, and Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

About Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan operating globally in major pharmaceutical markets, including Japan, the United States, China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area and the Oncology area, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about 6,500 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at


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Source: Sunovion Pharmaceuticals Inc.

Posted: March 2018

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