大冢和灵北精神分裂症药物Abilify Maintena获欧盟批准

大冢（Otsuka）和灵北（Lundbeck）11月21日宣布，长效版抗精神病药物Abilify Maintena（aripiprazole，阿立哌唑）上市许可申请（MAA）获欧盟委员会（EC）批准，作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。

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，同时疗效不逊色于口服阿立哌唑。

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的多巴胺D2部分激动剂，用于精神分裂症的维持治疗。

英文原文：Otsuka and Lundbeck's Once-Monthly
Abilify Maintena® (Aripiprazole) Now Approved in Europe for Maintenance Treatment of Schizophrenia in Adult Patients Stabilized with Oral Aripiprazole

Preventing relapse is critical in the treatment of schizophrenia. Pivotal studies, that supported the EU submission, demonstrate that Abilify Maintena can reduce the risk of relapse relative to placebo and is non-inferior to oral aripiprazole in patients with schizophrenia*1,2
The approval of Abilify Maintena now provides patients with schizophrenia access to a once-monthly formulation with established efficacy together with a tolerability profile that is comparable to that of oral ABILIFY® (aripiprazole)*2
At the end of the randomized, double-blind treatment phase in one of the pivotal trials, 93 percent of patients reported being extremely, very or somewhat satisfied with Abilify Maintena treatment*3
Abilify Maintena is the only dopamine D2 partial agonist in a once-monthly, injectable form to receive marketing authorization in Europe for maintenance treatment of schizophrenia
Abilify Maintena will be the first commercialized product in Europe from the global alliance between Otsuka and Lundbeck which is focused on developing Central Nervous System (CNS) therapies worldwide
(Tokyo, Japan and Copenhagen, Denmark, Thursday, November 21, 213) – Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced marketing authorization approval from the European Commission for Abilify Maintena (aripiprazole), an intramuscular (IM) once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

Abilify Maintena reduces the risk of relapse relative to placebo over the long-term and provides effective treatment of schizophrenia.*1,2 It has a tolerability profile similar to oral aripiprazole*1, and demonstrated statistically significant benefits on patients’ personal and social functioning as compared to placebo.*1,4 93 percent of patients treated with Abilify Maintena were extremely, very or somewhat satisfied with their treatment at the end of the double-blind treatment phase.*4

“We strongly believe the schizophrenia community will welcome the availability of Abilify Maintena to help improve outcomes for patients living with schizophrenia. As a company, our focus is to develop treatments to help protect against relapse and preserve brain function,” said Ole Vahlgren, CEO & President, Otsuka Europe. “We must partner with health care professionals and caregivers to help patients get the best treatments that focus on reducing the risk of relapse.”

“Studies have shown that the early use of long-acting injectables can prevent a person with schizophrenia from experiencing a relapse,”*5 said Ole Chrintz, SVP International Markets & Europe, Lundbeck. “Efficacy is important, but a treatment for a chronic condition such as schizophrenia also needs to be well tolerated so patients will stay on it over the long-term. We believe Abilify Maintena meets this need.”*1,2,3

About the Studies
The efficacy of Abilify Maintena was demonstrated in two double-blind, Phase III, randomized trials. The safety profile for Abilify Maintena was demonstrated to be similar to that of oral ABILIFY. The most frequently observed adverse drug reactions (ADRs) reported in ≥5 percent of patients in two double-blind controlled clinical trials of Abilify Maintena were weight increases (9.0 percent), akathisia (7.9 percent), insomnia (5.8 percent), and injection site pain (5.1 percent).*1,2

About Abilify Maintena
Abilify Maintena is the only dopamine D2 partial agonist in once-monthly, injectable form to receive marketing authorization for maintenance treatment in schizophrenia. Physicians now have an alternative treatment option, with a tolerability profile comparable to the well-established oral ABILIFY, to address the on-going need to reduce the risk of relapse in patients with schizophrenia.

The European label states that Abilify Maintena is a powder and solvent for prolonged-release suspension for intra-muscular (IM) injection. It is a once-monthly formulation of aripiprazole in a sterile lyophilized powder that is reconstituted with sterile water. Abilify Maintena is indicated for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole.

After the first injection, treatment with 10 mg to 20 mg oral aripiprazole should be continued for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy.

About Schizophrenia and Disease Relapse
Schizophrenia is a disease characterized by a distortion in the process of thinking and of emotional responsiveness. It most commonly manifests as hallucinations, paranoid or bizarre delusions, or disorganized speech and thinking, and is accompanied by significant social or occupational dysfunction. Onset of symptoms typically occurs in young adulthood, and the condition is chronic, often requiring lifelong treatment to mitigate symptoms.

Relapse of schizophrenia refers to an exacerbation or acute psychotic break that is characterised primarily by the emergence of positive symptoms such as hallucinations, delusions and disordered thinking.*6

Relapse can occur when a patient no longer responds to antipsychotic medication, does not take the medication as prescribed, or stops taking their medication altogether. There are many reasons patients stop taking their medication, including poor insight about their illness, side effects from current treatments, complicated medication regimen or lack of support from family.*7 Abilify Maintena is able to significantly reduce the risk of relapse in patients with schizophrenia.*1

It has been estimated that schizophrenia affects approximately one percent of the adult population in the U.S. and Europe, and approximately 24 million people worldwide.*8,9 In Europe there are approximately 4.4 million adults with schizophrenia,*10 prevalent equally in both genders.*11,12 While there is no cure for the disease, symptoms and risk of relapse can be managed in most patients with appropriate antipsychotic treatment. However, when the disease is not managed, patients are at increased risk of disease relapse, which can cause the re-emergence or worsening of psychotic symptoms.*13

Schizophrenia places a significant burden on society. It is regarded among the most financially costly illnesses and is according to the World Health Organization (WHO), the 8th leading cause of DALYs (lost healthy years) worldwide among patients between the age of 15-44.*11 With 50 percent of patients not receiving appropriate care and 80 percent of patients relapsing within the first 5 years,*14 there is a significant unmet need to be addressed in schizophrenia.