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住友及武田精神病药物Latuda获CHMP积极意见

来源:生物谷 2014-01-28 02:28

2014年1月27日讯 /生物谷BIOON/ --日本住友制药(Dainippon Sumitomo Pharma)和武田(Takeda)1月24日宣布,非典型抗精神病药物Latuda(lurasidone,鲁拉西酮)获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。CHMP建议批准Latuda用于精神分裂症(schizophrenia)成人患者的治疗。

CHMP的积极意见,是基于一项全面的临床试验项目。临床试验中,lurasidone已被证明能够有效治疗精神分裂症患者急性精神病性阳性症状(positive symptoms)和阴性症状(negative symptoms)。短期和长期研究中,lurasidone均表现出疗效,并具有低的代谢变化率,同时耐受性良好,体重增重率、血脂、血糖紊乱均较低。

Lurasidone是每日一次的非典型抗精神病口服治疗药物,对多巴胺D2、血清素5-HT2A、血清素5-HT7受体均具有高亲和力,对这些受体具有拮抗作用。此外,lurasidone还是血清素5-HT1A受体的部分激动剂,并对组胺或毒蕈碱(muscarinic)受体没有明显的亲和性。

Lurasidone由日本住友制药发现和开发,目前已获瑞士、美国、加拿大批准。(生物谷Bioon.com)

英文原文: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. In short and longer term clinical studies, lurasidone has demonstrated effectiveness with low rates of metabolic change. 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.

"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 and to be a well-tolerated, efficacious option for patients with schizophrenia switching medication.

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.

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. Switching antipsychotic medication is common in the treatment of patients with schizophrenia either due to residual or emergent symptoms, adverse events or tolerability issues.

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. Hospitalization associated with patient relapse can significantly increase costs associated with disease management in schizophrenia.

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