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Sunovion’s Latuda (lurasidone) Receives FDA Approval to Treat Adolescents with Schizophrenia

MARLBOROUGH, Mass.--(BUSINESS WIRE)--January 28, 2017 Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Latuda (lurasidone HCI) for the treatment of schizophrenia in adolescents aged 13 to 17 years. Latuda is also approved in the U.S. 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.

“The impact on development and poor prognosis frequently associated with schizophrenia that begins in adolescence underscores the need for treatment that is both well-tolerated and effective,” said Robert Findling, M.D., M.B.A., Vice President of Psychiatric Services and Research at the Kennedy Krieger Institute, Director of Child and Adolescent Psychiatry at the Johns Hopkins University School of Medicine and a study investigator. “The availability of Latuda provides healthcare providers with an important new option for helping adolescents with this illness that is chronic and severely disabling.”

The approval is based on results from a randomized, double-blind, placebo-controlled, six-week study in which adolescent patients with schizophrenia received fixed doses of Latuda 40 mg/day, Latuda 80 mg/day or placebo. At study endpoint, Latuda 40 mg/day and 80 mg/day were associated with statistical and clinical improvement in symptoms of schizophrenia compared to placebo. Latuda was also generally well tolerated with limited effects on weight and metabolic parameters.

“We are pleased that Latuda's range of indications has now expanded beyond the adult population to include the treatment of schizophrenia in adolescents aged 13 to 17 years. We believe that Latuda, as the first such medication in five years approved for adolescent patients with schizophrenia, is an important new treatment option for this difficult to treat illness,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “This approval builds on and reflects our commitment to advancing the treatment of serious psychiatric illness.”

The overall severity, impact on development and poor prognosis of adolescent schizophrenia highlight the need for early detection, prompt diagnosis and effective treatment.2 Adolescent schizophrenia has been characterized by a more severe onset of psychotic symptoms than adult-onset schizophrenia and is more likely to be preceded by social and developmental impairments.1,2 Additionally, delays to treatment from onset of psychotic symptoms may be two to three times longer for adolescents than adults and are associated with poorer treatment outcomes and response to treatment.3,4

About Schizophrenia

Schizophrenia is a chronic, serious and often severely disabling brain disorder. Symptoms such as hallucinations and delusions usually start between ages 16 and 30.7

Although rare in young children, incidence of schizophrenia rises during adolescence and peaks in early adulthood.2 Adolescent schizophrenia is associated with poor functioning prior to the onset of illness and early developmental delays.2 Similar types of early developmental and social impairments have been reported in adult-onset schizophrenia, but appear to be more common and severe in adolescents.2 A diagnosis of schizophrenia in adolescence may be a predictor of less independence, poorer educational achievement, lower likelihood of employment or access to further education, higher global disability scores and poor social relationships in adulthood.8

About Latuda

Latuda is used to treat patients with:

About Sunovion Pharmaceuticals Inc.

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. Sunovion’s track record of discovery, development and commercialization of important therapies has included Brovana® (arformoterol tartrate), Latuda® (lurasidone HCI), and most recently Aptiom® (eslicarbazepine acetate).

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, Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, and Sunovion CNS Development Canada ULC, based in Toronto, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company’s web sites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca. 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 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com.

BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc. LATUDA is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd. APTIOM is used under license from BIAL.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd. © 2017 Sunovion Pharmaceuticals Inc.

References

1 Veru F, et al. Schizophr Res. 2016; 174(1-3):183-188.
2 Hollis, C. BJPsych Advances. 2015; 21:333–341.
3 Dominguez MD, Fisher HL, Major B, et al. Schizophr Res. 2013; 150:526-532.
4 Perkins et al. Am J Psychiatry, 2005:162(10); 1785-1804
5Vitiello B, et al. Eur Neuropsychopharmacol. 2009; 19(9):629-635.
6 Correll CU, Carlson HE. J Am Acad Child Adolesc Psychiatry. 2006; 45(7):771-791.
7 National Institute of Mental Health. Schizophrenia. [Internet]. Available from: http://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml. Accessed January 2017.
8 Hollis, C. Am J Psychiatry. 2000; 157:1652-1659.

Source: Sunovion Pharmaceuticals Inc.

Posted: January 2017

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