Kyowa Kirin Announces Marketing Authorisation Application for Istradefylline Validated by European Medicines Agency

Kyowa Kirin公司用于治疗帕金森病患者的药物Istrafyline提交上市许可申请

2020-01-06 19:02:40 CISION


Kyowa Kirin Co., Ltd. President and CEO: Masashi Miyamoto, "Kyowa Kirin") today announces that its marketing authorisation application for istradefylline as an adjunctive treatment to levodopa-based regimens in adult patients with Parkinson's disease experiencing "OFF" time, has been validated by the European Medicines Agency and is now under review. This MAA is based on findings from randomised, multi-national, including EU, US and Japan double-blind, placebo-controlled trials in patients with PD taking a stable dose of levodopa-based regimens  with or without other PD medications. "Parkinson's disease is the fastest growing neurological disorder in the world in terms of prevalence, disability and deaths1," said Abdul Mullick, President, Kyowa Kirin International (Europe, Middle East and Africa (EMEA)). "There is significant need for new treatments for this debilitating condition. We are very excited about the possibility of bringing a new medicine to patients that works in a different way from current therapies. We look forward to working with the EMA during the review process." "I welcome the news of this validation, enabling the EMA to begin the review process," said Tomohiro Sudo, Head of Global Product Management Office, Kyowa Kirin, "We are committed to providing this innovative medicine as a new treatment option for Parkinson's disease patients who need more treatments to improve their situation. We will keep making our best efforts to improve the lives of patients in the European Union." The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies. About Kyowa Kirin Kyowa Kirin commits to innovative drug discovery driven by state-of-the-art technologies. Kyowa Kirin focuses on creating new values in the four therapeutic areas: nephrology, oncology, immunology/allergy and neurology. Under the Kyowa Kirin brand, the employees from 36 group companies across North America, Europe and Asia/Oceania unite to champion the interests of patients and their caregivers in discovering solutions wherever there are unmet medical needs. You can learn more about the business of Kyowa Kirin at About istradefylline Istradefylline is an orally administered, selective adenosine A2A receptor antagonist. Istradefylline was approved in Japan (product name: NOURIAST®) in March 2013 for improving the "wearing-off" phenomenon in patients with Parkinson's disease on levodopa-containing preparations. Istradefylline was also approved in the US (product name: NOURIANZTM) in August 2019 for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease experiencing "off" episodes. About Parkinson's disease Parkinson's disease is a progressive, neurodegenerative disease characterized by motor symptoms such as tremors, rigidity, slow movement and postural instability. It is thought to be caused by progressive degeneration associated with decreased levels of dopamine in certain parts of the brain, i.e., the substantia nigra and striatum. 1 [GBD 2016 Parkinson's Disease Collaborator Group. Lancet Neurol 2018; 17: 939 - 953] SOURCE Kyowa Kirin International
Kyowa Kirin Co . Ltd .总裁兼首席执行官: Masashi Miyamoto ,“ Kyowa Kirin ”)今天宣布,其上市许可申请,作为对患有“ OFF ”时间的成年帕金森病患者左旋多巴方案的辅助治疗,已经获得欧洲药品管理局的认证,目前正在审查中。 该 MAA 是基于随机、多国研究的结果,包括欧盟、美国和日本的双盲、安慰剂对照试验,对 PD 患者采用稳定剂量的左旋多巴为主的治疗方案,不论是否使用其他 PD 药物。 “帕金森病是世界上发病率、致残率和死亡率增长最快的神经疾病,” Kyowa Kirin International (欧洲、中东和非洲)总裁 Abdul Mullick 说。“对于这种衰弱的状况,需要新的治疗方法。我们非常兴奋的是,有可能给与目前疗法不同的病人带来一种新的药物。我们期待着在审查过程中与欧洲经货局合作。” Kyowa Kirin 全球产品管理办公室主任 Tomohiro Sudo 说:“我欢迎这一验证的消息,使 EMA 能够开始审查过程。”我们致力于为需要更多治疗以改善病情的帕金森病患者提供这一创新药物。我们将继续尽最大努力改善欧盟病人的生活。” Kyowa Kirin 集团公司通过追求生命科学和技术的进步创造新的价值,努力为全世界人民的健康和福祉作出贡献。 关于 Kyowa Kirin Kyowa Kirin 致力于以最先进技术为驱动的创新药物发现。Kyowa Kirin 致力于在四个治疗领域创造新的价值:肾脏病学、肿瘤学、免疫学/变态反应和神经病学。在 Kyowa Kirin 品牌下,来自北美、欧洲和亚洲/大洋洲36家集团公司的员工团结在一起,共同维护患者及其照顾者的利益,以发现任何没有得到满足的医疗需求的解决方案。 您可以在 上了解更多关于 Kyowa Kirin 业务的信息 关于裁判法院 Istrafylline 是一种口服的选择性腺苷 A2A 受体拮抗剂。Istratfylline 于2013年3月在日本获得批准(产品名称: NOURIAST ®),用于改善含左旋多巴制剂帕金森病患者的“穿着”现象。Istratfylline 还于2019年8月在美国获得批准(产品名称: NOURIANZTM ),用于对患有帕金森病的成人患者进行左旋多巴/卡比多巴的辅助治疗。 关于帕金森病 帕金森病是一种进行性的神经退行性疾病,其特征是运动症状如震颤、僵硬、运动缓慢和体位不稳定。它被认为是由于大脑某些部位多巴胺水平下降而导致的渐进性退化,即黑质和纹状体。 1[ GBD 2016帕金森病协作组。Lancet Neuroll 2018;17:939-953] SoURCE Kyowa Kirin International