Sunovion Resubmits New Drug Application for Apomorphine Sublingual Film

住友制药帕金森新药阿扑吗啡舌下薄膜再次申请美国上市

2019-11-29 18:00:18 drugs

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Sunovion Pharmaceuticals Inc. today announced the resubmission of the New Drug Application to the U.S. Food and Drug Administration for apomorphine sublingual film to treat motor fluctuations experienced by people living with Parkinson’s disease in response to the January 29, 2019 Complete Response Letter . This submission included information about intended packaging as well as additional analyses of clinical data. Apomorphine sublingual film is being developed as a fast-acting medicine for the on-demand treatment of all types of motor OFF episodes, including morning OFF, unpredictable OFF and end-of-dose wearing OFF. OFF episodes can cause severe disruption for someone living with PD, often causing a major disturbance in a person’s ability to maintain everyday activities. OFF episodes may worsen in frequency and severity over the course of the illness.1 While OFF episodes are experienced by 40 to 60 percent of people with PD, there are limited on-demand treatment options available for motor OFF episodes.2 “OFF episodes in people with Parkinson’s disease can occur at any point throughout the day, often occurring in the morning after awakening and periodically throughout the day and can disrupt the ability to perform everyday activities,” said Antony Loebel, M.D., President and Chief Executive Officer at Sunovion. “We look forward to continuing our dialogue with the FDA during the review period with the intention of bringing a much needed on-demand treatment option for OFF episodes to those living with Parkinson’s disease.” Apomorphine sublingual film (APL-130277), a novel formulation of apomorphine, a dopamine agonist, is being developed as a fast-acting on-demand treatment of OFF episodes associated with Parkinson’s disease (PD). Apomorphine sublingual film is designed to offer a potential option that may be used to treat OFF episodes associated with PD up to five times throughout the day. It may help people with PD rapidly convert from the OFF to the ON state. Apomorphine sublingual film has not been approved by the U.S. Food and Drug Administration (FDA). In October 2016, Sunovion acquired Cynapsus Therapeutics Inc. (Canadian Specialty Central Nervous System Biotechnology Company), along with its product candidate APL-130277. By 2020 nearly one million people in the U.S. and an estimated 10 million people worldwide will be living with Parkinson’s disease (PD).3 PD is a chronic, progressive neurodegenerative disease characterized by motor symptoms, including tremor at rest, rigidity and impaired movement, as well as significant non-motor symptoms, including cognitive impairment and mood disorders. It is the second most common neurodegenerative disease behind Alzheimer’s disease, and the prevalence of PD is increasing with the aging of the population. OFF episodes are the worsening or re-emergence of PD symptoms (motor and non-motor) otherwise controlled by medications. These episodes may disrupt a person’s ability to perform everyday activities and may be burdensome for patients, family and caregivers. OFF episodes are experienced by 40 to 60 percent of people with PD and may worsen in frequency and severity over the course of the illness.2 Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s vision is to lead the way to a healthier world. The company’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions. Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company’s websites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube. Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the Oncology area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com. References Source: Sunovion Pharmaceuticals Inc. Posted: November 2019 APL-130277 (apomorphine) FDA Approval History
Sunovion Pharmaceuticals Inc .今日宣布重新向美国食品药品监督管理局(Food and Drug Administration)提交新药申请,用于治疗帕金森病患者于2019年1月29日收到的运动波动的阿扑吗啡舌下膜。提交的材料包括关于预期包装的信息以及对临床数据的额外分析。 阿扑吗啡舌下膜是一种快速作用药物,用于按需治疗各种类型的运动 OFF 发作,包括早晨 OFF 、不可预测的 OFF 和剂量末穿 OFF 。OFF 事件可能会对 PD 患者造成严重的干扰,通常会对一个人维持日常活动的能力造成重大干扰。在病程中, OFF 发作的频率和严重程度可能会恶化。1虽然有40%至60%的 PD 患者经历了 OFF 发作,但可用于运动 OFF 发作的按需治疗选择有限。2 Sunovion 公司总裁兼首席执行官安东尼·洛贝尔( Antony Loebel )说:“帕金森病患者的 OFF 发作可以在一天中的任何时候发生,通常发生在觉醒后的早上,而且会在一天中周期性地发生,并可能破坏日常活动的能力。”“我们期待在审查期间继续与 FDA 进行对话,为患有帕金森病的患者提供急需的 OFF 治疗方案。” 阿朴吗啡舌下膜( APL-130277)是一种新型的多巴胺激动剂阿朴吗啡的制剂,目前正被开发成一种快速按需治疗与帕金森病( PD )相关的 OFF 发作。阿朴吗啡舌下膜的目的是提供一个潜在的选择,可以用来治疗 OFF 事件相关的 PD 长达五次整个一天。它可以帮助 PD 患者从 OFF 快速转换到 ON 状态。吗啡舌下含片尚未获得美国食品药品监督管理局(Food and Drug Administration)( FDA )的批准。2016年10月, Sunovion 收购 Cynasus Therapeutics Inc .(加拿大特殊中枢神经系统生物技术公司),及其产品候选企业 APL-130277。 到2020年,美国将有近100万人,全世界估计有1000万人将患上帕金森病。3 PD 是一种以运动症状为特征的慢性进行性神经退行性疾病,包括静止颤抖、僵硬和运动障碍,以及明显的非运动症状,包括认知障碍和情绪障碍。它是阿尔茨海默氏症后第二常见的神经退行性疾病,随着人口老龄化, PD 患病率也在增加。OFF 发作是 PD 症状(运动和非运动)恶化或再次出现,否则由药物控制。这些插曲可能会破坏一个人执行日常活动的能力,并可能给病人、家人和照顾者带来负担。有40%至60%的 PD 患者出现 OFF 发作,在病程中出现频率和严重程度的恶化。2 Sunovion 公司是一家全球生物制药公司,专注于科学和医学的创新应用,帮助有严重医疗状况的人。Sunovion 的愿景是引领走向更健康的世界。公司的创新精神源于一种信念,即科学的卓越加上有意义的宣传和相关教育能够改善生活。随着患者处于其所做一切的中心, Sunovion 绘制了新的途径,以改变生活的治疗,反映了持续的研发投资和坚定的承诺,以支持人的精神,神经和呼吸条件。 总部设在马萨诸塞州马尔伯勒。Sunovion 是住友(Sumitomo) Dainippon Pharma Co ., Ltd . Sunovion Pharmaceuticals Europe Ltd .的间接全资子公司,总部位于英国伦敦, Sunovion Pharmaceuticals Canada Inc .,总部位于安大略省 Mississauga 。是 Sunovion Pharmaceuticals Inc .的全资直接子公司。更多信息请参见公司网站:\160; www.sunovion.com , www.sunovion.eu \160;和\160; www.sunovion.ca 与 Sunovion 在 Twitter 、 LinkedIn 、 Facebook 和 YouTube 上的连接。 住友(Sumitomo) Dainippon Pharma 是日本十大上市医药企业之一,在全球主要医药市场经营,包括日本、美国、中国和欧盟。住友(Sumitomo) Dainippon Pharma 旨在在已被指定为重点治疗领域的精神病学和神经学领域、肿瘤领域和再生医学/细胞治疗领域打造创新药产品。住友 Dainippon Pharma 是以2005年 Dainippon Pharmaceutical Co ., Ltd 与 Sumitomo Pharmaceuticals Co ., Ltd 合并为基础,目前住友(Sumitomo) Dainippon Pharma 在全球拥有6000多名员工。关于住友(Sumitomo) Dainippon Pharma 的其他信息可通过其公司网站 https://www.ds-pharma 查阅。com 。 参考文献 资料来源: Sunovion 制药公司。 张贴日期:2019年11月 APL-130277(吗啡) FDA 批准历史

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