灵北和大冢在欧洲推出长效精神分裂症药物Abilify Maintena

灵北和大冢在欧洲推出长效精神分裂症药物Abilify Maintena
[size=1.1em]作者：[size=1.1em]tomato[size=1.1em]来源：[size=1.1em]生物谷2014-3-17 18:21:10

关键词： 灵北 大冢 精神分裂症 Abilify Maintena 阿立哌唑

                               
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2014年3月17日讯 /生物谷BIOON/ --灵北（Lundbeck）和大冢（Otsuka）3月17日宣布，在欧盟推出长效版精神分裂症药物Abilify Maintena（aripiprazole，阿立哌唑），该药为每月一次的肌内注射（IM）剂型药物，用于口服阿立哌唑稳定病情的精神分裂症（schizophrenia）成人患者的维持治疗。目前，Abilify Maintena已获FDA、欧盟、加拿大批准。

防止复发是治疗精神分裂症的关键。支持Abilify Maintena监管文件的关键性研究证明，在精神分裂症的长期治疗中，与安慰剂相比，Abilify Maintena能够降低复发的风险，而且疗效不逊色于口服阿立哌唑。

此外，Abilify Maintena具有与口服阿立哌唑类似的耐受性，同时，与安慰剂相比，Abilify Maintena在患者个人和社会功能上表现出统计学意义的显著改善，在双盲治疗阶段结束时，高达93%的患者对Abilify Maintena治疗表现出及其满意、非常满意或有点满意。

在欧洲，Abilify Maintena是唯一一种每月一次的注射剂型多巴胺D2部分激动剂，用于精神分裂症的维持治疗。（生物谷Bioon.com）

英文原文：Lundbeck and Otsuka initiate European launch of Abilify Maintena® (aripiprazole), a once-monthly formulation for the treatment of schizophrenia

—Abilify Maintena® gives patients long-term protection from relapse*, one of the key goals in the treatment of schizophrenia, by delaying time to and reducing the risk of relapse. Relapse, particularly in the early course of the disease, can have a profound detrimental impact on the patients' long-term prognosis.

—Abilify Maintena® provides people diagnosed with schizophrenia access to a once-monthly formulation with a favourable tolerability profile that is comparable to that of oral ABILIFY® (aripiprazole).

—In Europe, relapses, and the resulting progressive functional decline can lead to increased healthcare costs, mainly driven by recurrent and prolonged hospital stays.

H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Europe Ltd. (Otsuka) today announced the launch of Abilify Maintena in Europe following approval by the European Commission in November 2013. Abilify Maintena is now available in a number of European countries and is progressing through the various Healthcare Authorities that provide access to patients. Denmark is the first European country where Abilify Maintena is fully reimbursed and accessible to people with schizophrenia, and more than ten markets are expected to launch by the end of 2014.

Abilify Maintena (aripiprazole) is an intramuscular (IM), once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

In clinical trials, Abilify Maintena provided protection from relapse over the long term with over 90% of patients remaining relapse-free at the end of the study period[v],[vi] . It offers long-term control of positive and negative symptoms and can help preserve patients' personal and social functioning while offering a favourable tolerability profile similar to oral aripiprazole6

"We are very pleased to bring once-monthly Abilify Maintena to people diagnosed with schizophrenia" said Ole Chrintz, Senior Vice President, International Markets and Europe at Lundbeck. "Patients early in the course of their disease may have the most to gain from a long-acting treatment that reduces their risk of relapse over the long term and can help them maintain personal and social functioning."

Ole Vahlgren, CEO & President, Otsuka Europe noted "The clinical and economic burden of schizophrenia is substantial. The majority of patients who try long-acting injections tend to prefer them over their previous oral formulations. We are committed to working with local governments and healthcare authorities to make Abilify Maintena available to patients in every European country".

Abilify Maintena was approved by the FDA for the treatment of schizophrenia in the US in February 2013 and has recently received a marketing authorization for the maintenance treatment of schizophrenia in stabilized adult patients in Canada.

(责任编辑：lishuheng)