Click here to close now.



Welcome!

News Feed Item

Dainippon Sumitomo Pharma and Takeda Receive Positive CHMP Opinion for Lurasidone - a New Atypical Antipsychotic Medication for Adults with Schizophrenia

OSAKA, Japan, January 24, 2014 /PRNewswire/ --

Dainippon Sumitomo Pharma Co., Ltd. ("DSP") (Head Office: Osaka, Japan) and Takeda Pharmaceutical Company Limited ("Takeda") (Head Office: Osaka, Japan) today jointly announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), has issued a Positive Opinion for lurasidone for the treatment of schizophrenia in adults. Lurasidone is a once-daily oral treatment that is currently available in Switzerland, the United States and Canada having been approved for use by the respective regulatory authorities.

The Positive CHMP Opinion was based on a comprehensive clinical trial program which included placebo and active comparators. Lurasidone was shown to be effective in treating both positive and negative symptoms in acutely psychotic patients with schizophrenia over 6 weeks.[1],[2],[3],[4],[5]In short and longer term clinical studies, lurasidone has demonstrated effectiveness with low rates of metabolic change.[1],[2],[6]  It is important to minimize the adverse effect of treatments on long-term physical health as patients are likely to remain on therapy for many years.

Lurasidone was generally well-tolerated and had low rates of weight increase, as well as lipid and glucose disturbance, in the treatment of patients with schizophrenia. The most frequent adverse reactions seen in short-term clinical studies (incidence ≥ 5% and at least twice as frequent as with placebo) were somnolence, akathisia, nausea, Parkinsonism and dystonia.[7]

"As a practicing psychiatrist, I am interested in new, effective agents for the treatment of severely ill patients with mental disorders. We need effective, well-tolerated and metabolically neutral treatment alternatives. Lurasidone has an interesting profile, which could benefit many patients with schizophrenia" says Philipp Eich MD, Klinik für Psychiatrie und Psychotherapie, Liestal, Switzerland.

Data for lurasidone was presented at last year's European College of Neuropsychopharmacology (ECNP) Congress showing lurasidone to have a favourable metabolic side effect profile[8],[9],[10],[11] and to be a well-tolerated, efficacious option for patients with schizophrenia switching medication.[11]

About Lurasidone

Lurasidone is an atypical antipsychotic, developed originally by Dainippon Sumitomo Pharma Co., Ltd. ("DSP") with a high affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonistic effects. In addition, lurasidone is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine or muscarinic receptors. Lurasidone was approved for the treatment of schizophrenia by the United States Food and Drug Administration in October 2010, by Health Canada in June 2012, and by the Swiss Agency for Therapeutic Products in August 2013. Lurasidone was launched as LATUDA® for the treatment of schizophrenia in adults in the United States in February 2011 and in Canada in September 2012 through DSP's subsidiary Sunovion Pharmaceuticals Inc., and in Switzerland in September 2013 through Takeda. In Japan a Phase III clinical study is underway for the treatment of schizophrenia by DSP.  An application has been filed with the Australian Therapeutic Goods Administration for the treatment of patients with schizophrenia, as well as the Taiwan Food and Drug Administration (TFDA) and further development in the Chinese and Southeast Asian markets is planned.

About schizophrenia

Schizophrenia is a severe chronic mental condition which can affect both men and women. Patients with schizophrenia have a life span that is decreased by approximately 10-22.5 years compared with the general population.[1][2],[13],[14],[15]

Antipsychotic pharmacotherapy is the cornerstone of treatment for patients with schizophrenia, with agents generally classed as typical or atypical. Atypical agents are broadly considered to have tolerability benefits over typical agents.[16] Switching antipsychotic medication is common in the treatment of patients with schizophrenia either due to residual or emergent symptoms, adverse events or tolerability issues.[17],[18]

Direct and indirect costs associated with caring for patients with schizophrenia are considerable and can include utilization of other health services, pharmacotherapy, community care, supportive therapy, informal care and private expenditures, and patient and caregiver lost productivity.[19],[20] Hospitalization associated with patient relapse can significantly increase costs associated with disease management in schizophrenia.[21]

About Dainippon Sumitomo Pharma Co., Ltd.

Dainippon Sumitomo Pharma Co., Ltd., defines its corporate mission as "to broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives for people worldwide". By pouring all our efforts into the research and development of new drugs, we aim to provide innovative and effective pharmaceutical solutions to people not only in Japan but also around the world in order to realize our corporate mission. Additional information about DSP is available through its corporate website, http://www.ds-pharma.com.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, http://www.takeda.com.


References

  1. Meltzer H et al. Am J Psychiatry 2011;168:957-67
  2. Loebel A et al. Schizophr Res 2013;145(1-3):101-9
  3. Nakamura M et al. J Clin Psychiatry 2009;70:829-36
  4. Ogasa M et al. Psychopharmacol [Berl] 2013;225(3):519-30
  5. Nasrallah H et al. J Psychiatric Research 2013;47(5):670-7
  6. Citrome L et al. Int Clin Psychopharmacol 2012;27:165-76
  7. Company Core Data Sheet (Table 4).
  8. Murthy et al. Lurasidone for the treatment of schizophrenia: pooled analysis of short-term, placebo-controlled trials (Abstract presented at ECNP, 8 October 2013)
  9. Lieberman J.A. et al. Lurasidone in the treatment of early-stage schizophrenia: a post-hoc analysis of three pooled acute treatment studies (Abstract presented at ECNP, 8 October 2013)
  10. Pikalov A et al. Eur Neuropsychopharmacol 2012;22(Suppl 2):S340
  11. McEvoy J.P.et al. Switching to lurasidone in patients with schizophrenia: tolerability and effectiveness at 6 weeks and 6 months (Abstract presented at ECNP, 8 October 2013)
  12. Healy D et al. Mortality in schizophrenia and related psychoses: data from two cohorts, 1875-1924 and 1994-2010. BMJ Open 2012;2:e001810
  13. Chang C-K et al. Life Expectancy at Birth for People with Serious Mental Illness and Other Major Disorders from a Secondary Mental Health Care Case Register in London. PLoS One 2011;6:e19590
  14. Laursen TM. Life expectancy among persons with schizophrenia or bipolar affective disorder. Schizophr Res 2011;131:101-4
  15. Tiihonen J et al. 11 year-follow up of mortality in patients with schizophrenia: a population-based cohort study (FINN11 study). Lancet 2009;374:620-7
  16. Lewis DA and Lieberman JA. Neuron 2000;28:325-34
  17. Faries DE et al. Clinical and economic ramifications of switching antipsychotics in the treatment of schizophrenia. BMC Psych 2009;9:54
  18. Tsutsumi C et al. The evolution of antipsychotic switch and polypharmacy in natural practice - A longitudinal perspective. Schizophr Res 2011;130:40-6
  19. Salize HJ et al. Cost of schizophrenia in six European countries. Schizophr Res 2009;111(1-3):70-7
  20. Mangalore R and Knapp R. Cost of schizophrenia in England. J Ment Health Policy Econ 2007;10(1):23-41
  21. Zeidler J et al. The costs of schizophrenia and predictors of hospitalisation from the statutory health insurance perspective. Health Econ Rev 2012;2(1):9


More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Companies can harness IoT and predictive analytics to sustain business continuity; predict and manage site performance during emergencies; minimize expensive reactive maintenance; and forecast equipment and maintenance budgets and expenditures. Providing cost-effective, uninterrupted service is challenging, particularly for organizations with geographically dispersed operations.
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed...
When building large, cloud-based applications that operate at a high scale, it’s important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. “Fly two mistakes high” is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Lee...
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
DevOps is not just last year’s buzzword. Companies with DevOps practices are 2.5x more likely to exceed profitability, market share, and productivity goals. But how do you enable high performance? What can you do right now to start? Find out from DevOps experts including Gene Kim, co-author of "The Phoenix Project," and the Dynatrace Center of Excellence.
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
SYS-CON Events announced today that Column Technologies will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Established in 1998, Column Technologies is a global technology solutions provider with over 400 employees, headquartered in the United States with offices in Canada, India, and the United Kingdom. Column Technologies provides “Best of Breed” technology solutions that automate the key DevOps principal...
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
There will be new vendors providing applications, middleware, and connected devices to support the thriving IoT ecosystem. This essentially means that electronic device manufacturers will also be in the software business. Many will be new to building embedded software or robust software. This creates an increased importance on software quality, particularly within the Industrial Internet of Things where business-critical applications are becoming dependent on products controlled by software. Qua...
As someone who has been dedicated to automation and Application Release Automation (ARA) technology for almost six years now, one of the most common questions I get asked regards Platform-as-a-Service (PaaS). Specifically, people want to know whether release automation is still needed when a PaaS is in place, and why. Isn't that what a PaaS provides? A solution to the deployment and runtime challenges of an application? Why would anyone using a PaaS then need an automation engine with workflow ...
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Avere delivers a more modern architectural approach to storage that doesn’t require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbuilding of data centers ...
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
CIOs and those charged with running IT Operations are challenged to deliver secure, audited, and reliable compute environments for the applications and data for the business. Behind the scenes these tasks are often accomplished by following onerous time-consuming processes and often the management of these environments and processes will be outsourced to multiple IT service providers. In addition, the division of work is often siloed into traditional "towers" that are not well integrated for cro...