Health Canada Approves EVENITY For the Treatment of Osteoporosis in Postmenopausal Women at High Risk for Fracture

加拿大卫生部批准EVENITY用于治疗高骨折风险的骨质疏松症

2019-10-09 01:40:07 BioSpace

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MISSISSAUGA, ON, Oct. 8, 2019 /CNW/ - Today Amgen Canada announced that EVENITY® is now available in Canada for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture. "We are pleased with Health Canada's decision to approve EVENITY and allow patients access to a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures," says Ponda Motsepe-Ditshego, Executive Medical Director at Amgen Canada. "Two million Canadians are affected by osteoporosis,2 and this approval provides a new option for physicians when treating patients who may be at risk." Osteoporosis is a serious, chronic condition with no cure.3 According to the World Health Organization (WHO), osteoporosis is a major public health crisis, affecting millions of people worldwide. In Canada the disease is responsible for over 80 per cent of all fractures in people over 50.2 After the initial fractures, one in two hip fracture patients in Canada will suffer another fracture within five years.2 Fewer than 20 per cent of fracture patients in Canada currently undergo diagnosis or adequate treatment for the disease.2 "Despite advances over the past few decades, many Canadian patients are still not being diagnosed and treated for osteoporosis," said Dr. Rick Adachi, Professor of Medicine at the Michael DeGroote School of Medicine at McMaster University, Hamilton, Ontario, Canada. "With the approval of EVENITY, physicians and their patients now have another proven treatment option to reduce the risk of these life-altering fractures." "Osteoporosis is a major health burden, impacting more than two million people across Canada, and the availability of EVENITY puts us one step closer to decreasing the rates of debilitating osteoporotic fractures," said Dr. Famida Jiwa, President and CEO, Osteoporosis Canada. The Canadian approval of EVENITY was based on the results of two Phase 3 studies that demonstrated a reduction of new vertebral (spine) fractures and increased bone mineral density (BMD). About EVENITY® EVENITY is a bone formation humanized monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin, which simultaneously results in increased bone formation and to a lesser extent decreased bone loss. The EVENITY development program includes 19 clinical studies that enrolled more than 14,000 patients globally. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program that included two large fracture trials comparing EVENITY to either placebo or active comparator in nearly 12,000 postmenopausal women with osteoporosis.  Important Safety Information1 EVENITY is contraindicated in patients who are hypersensitive to romosozumab or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. EVENITY is contraindicated in patients with hypocalcemia. Correct pre-existing hypocalcemia prior to initiating treatment with EVENITY. The overall safety of EVENITY was studied in 19 clinical trials involving over 14,000 patients, with the Phase 3 program consisting of nearly 12,000 patients. EVENITY has a Serious Warnings and Precautions Box in its product label which advises that EVENITY may increase the risk of myocardial infarction (heart attack), stroke and cardiovascular death. EVENITY is not recommended in patients who have had a heart attack or stroke. Consider whether the benefits outweigh the risks in patients with other cardiovascular or cerebrovascular disease or associated risk factors. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY should be discontinued. More information on Adverse Reactions may be found in the EVENITY Product Monograph. About the Pivotal EVENITY Clinical Trials FRAME (Fracture study in postmenopausal women with osteoporosis) is a randomized, double-blind, placebo-controlled study (Study 1) that evaluated 7,180 postmenopausal women with osteoporosis. The study evaluated the efficacy of EVENITY treatment (210 mg administered monthly), compared with placebo and showed a reduction of new vertebral (spine) fractures at 12 months compared to placebo. This reduction in fracture risk persisted through the second year in women who received EVENITY during the first year and transitioned to denosumab compared to those who transitioned from placebo to denosumab. In addition, EVENITY increased BMD at the lumbar spine, total hip and femoral neck compared to placebo at 12 months. Following the transition from EVENITY to denosumab at month 12, BMD continued to increase through month 24.4 ARCH (Active-controlled fracture study in postmenopausal women with osteoporosis at high risk of fracture) is a randomized, double-blind, alendronate-controlled study (Study 2) of EVENITY in 4,093 postmenopausal women with osteoporosis and previous fracture history. This event-driven study evaluated 12 months of EVENITY treatment (210 mg administered monthly) followed by at least 12 months of alendronate treatment (70 mg), compared with alendronate treatment alone and showed a reduced incidence of new vertebral fracture at 24 months. EVENITY followed by alendronate reduced the risk of clinical fracture (defined as a composite of symptomatic vertebral fracture and nonvertebral fracture) after a median follow-up of 33 months. EVENITY increased BMD at the lumbar spine, total hip and femoral neck at 12 months compared to alendronate. Twelve months of treatment with EVENITY followed by 12 months of treatment with alendronate increased BMD compared with alendronate alone.5 About Osteoporosis Osteoporosis is a condition that causes bones to become thin and porous, decreasing bone strength and leading to increased risk of breaking a bone.2 The most common sites of broken bones from osteoporosis are the wrist, spine, shoulder and hip.2 Osteoporosis can strike at any age, however it mainly affects women after menopause as their ability to form new bone cannot counterbalance the rate at which bone is being resorbed.2,3 This bone loss leads to weakened bones over time, increasing the potential for a break.2 At least one in three women and one in five men will suffer a broken bone from osteoporosis during their lifetime.2 Broken bones from osteoporosis are more common than heart attack, stroke and breast cancer combined.2 One in three people who break a hip will re-break it at one year, and over one in two will suffer another bone break within five years.2 The World Health Organization has officially declared osteoporosis a public health crisis6, while the International Osteoporosis Foundation urges governments worldwide to make osteoporosis a healthcare priority.7 About Amgen Canada As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.'s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new uses for existing medicines in partnership with many of Canada's leading health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca. Amgen Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. 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We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to acquire other companies or products and to integrate the operations of companies Amgen has acquired may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all. References EVENITY™ Product Monograph. Amgen Canada Inc. (June 2019). Osteoporosis Canada. Osteoporosis Facts and Statistics. https://osteoporosis.ca/about-the-disease/fast-facts/ Accessed June 19, 2019. International Osteoporosis Foundation. The Global Burden of Osteoporosis: A Factsheet. Available at: https://iofbonehealth.org/sites/default/files/media/PDFs/Fact%20Sheets/2014-factsheet-osteoporosis-A4.pdf. Accessed June 19, 2019. Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME). Available at: https://clinicaltrials.gov/ct2/show/NCT01575834?term=NCT01575834&rank=1. Accessed June 5, 2019. Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis (ARCH). Available at: https://clinicaltrials.gov/ct2/show/NCT01631214?term=NCT01631214&rank=1. Accessed June 5, 2019. The World Health Organization. Bulletin of the World Health Organization. Exercise interventions: defusing the world's osteoporosis time bomb. Available at: http://www.who.int/bulletin/volumes/81/11/mingchanwa1103.pdf. Accessed April 2019. International Osteoporosis Foundation. Global Initiatives. Available at http://www.iofbonehealth.org/global-initiatives-0. Accessed April 2019. SOURCE Amgen Canada
今天,加拿大安进(Amgen)公司宣布, EVENITY ®现已在加拿大上市,用于治疗绝经后高骨折风险妇女的骨质疏松,定义为骨质疏松史,或骨折的多种危险因素。 “我们很高兴加拿大卫生部决定批准 EVENITY ,并允许患者获得一种能迅速增加骨密度并有助于降低未来骨折风险的药物,”加拿大安进(Amgen)公司执行医学主任 Ponda Motsese-Ditshego 说。200万加拿大人受骨质疏松症的影响,这一批准为医生治疗可能有危险的病人提供了一个新的选择。 骨质疏松症是一种严重的慢性疾病,没有治愈。3据世界卫生组织(世卫组织)称,骨质疏松症是一场重大的公共卫生危机,影响到全世界数百万人。在加拿大,这种疾病占50.2岁以上人群骨折总数的80%以上。在最初的骨折后,加拿大每两名髋关节骨折患者中就有一人在五年内再次骨折。加拿大目前只有不到20%的骨折患者接受诊断或适当治疗。2 加拿大安大略省汉密尔顿麦克马斯特大学迈克尔·德格罗特医学院的医学教授里克·阿德奇博士说:“尽管过去几十年来取得了一些进展,但许多加拿大患者仍未被诊断和治疗骨质疏松。”经过 EVENITY 的批准,医生和他们的病人现在有了另一种被证明有效的治疗方法来降低这些改变生命的骨折的风险。 加拿大骨质疏松症协会主席兼首席执行官 Famida Jiwa 博士说:“骨质疏松症是一种主要的健康负担,影响了加拿大两百多万人,而 EVENITY 的出现使我们更加接近于降低骨质疏松骨折的发生率。” 加拿大批准 EVENITY 的依据是两项3期研究的结果,这两项研究表明新椎骨(脊柱)骨折减少,骨密度增加。 关于 EVENITY ® EVENITY 是一种骨形成人源化单克隆抗体。它的目的是通过抑制硬化剂的活性来发挥作用,同时导致骨形成增加,并在较小程度上减少骨丢失。EVENITY 开发计划包括19项临床研究,在全球注册了14,000多名患者。EVENITY 已被研究其在广泛的全球第3阶段计划中降低骨折风险的潜力,该计划包括两项大型骨折试验,将 EVENITY 与安慰剂或在近12,000名绝经后骨质疏松妇女中的积极参照物进行比较。 重要安全资讯1 对罗莫索单或制剂中的任何成分(包括任何非药用成分或容器的成分)过敏的患者禁止使用 EVENITY 。 低钙血症患者的 EVENITY 是相反的。在开始使用 EVENITY 治疗之前纠正先前存在的低钙血症。 EVENITY 的整体安全性在19项临床试验中进行了研究,涉及14,000多名患者,第三阶段方案由近12,000名患者组成。 EVENITY 在其产品标签中有一个严重警告和预防框,建议 EVENITY 可能增加心肌梗死(心脏病发作)、中风和心血管死亡的风险。患有心脏病或中风的患者不推荐使用 EVENITY 。考虑利益是否大于其他心血管或脑血管疾病或相关风险因素患者的风险。如果患者在治疗过程中经历了心肌梗死或中风,那么 EVENITY 应该停止。 关于不良反应的更多信息可以在 EVENITY 产品目录中找到。 关于透视 EVENITY 临床试验 FRAME (骨质疏松绝经后妇女骨折研究)是一项随机、双盲、安慰剂对照的研究(研究1),评估了7180名绝经后妇女骨质疏松症。这项研究评估了 EVENITY 治疗的疗效(每月210毫克给药),与安慰剂相比,并显示在12个月内新椎体(脊柱)骨折的减少与安慰剂相比。在第一年接受 EVENITY 的妇女中,骨折风险的降低一直持续到第二年,与从安慰剂过渡到去苏门答腊的妇女相比,她们过渡到去苏门答腊。此外,与安慰剂12个月相比, EVENITY 在腰椎、总髋和股骨颈增加了 BMD 。在从 EVENITY 到12月12日的转变之后, BMD 在24.4个月中持续增长 ARCCH 是一项随机、双盲、阿仑膦酸控制的研究(研究2),研究对象是4,093名绝经后骨质疏松和以往骨折病史的妇女。这项由事件驱动的研究评估了12个月的 EVENITY 治疗(210毫克每月给药),随后至少12个月的阿仑膦酸钠治疗(70毫克),相比单独阿仑膦酸钠治疗,并显示新的脊椎骨折的发生率在24个月减少。平均随访33个月后,阿仑膦酸钠降低了临床骨折(定义为有症状的椎体骨折和非椎体骨折的复合)的风险。与阿伦膦酸盐相比,12个月时腰椎、髋关节和股骨颈的 BMD 均有增加。治疗12个月的 EVENITY 后,12个月的阿仑膦酸治疗增加了 BMD 相比,阿仑膦酸单独。5、5 关于骨质疏松症 骨质疏松症是一种导致骨骼变薄和多孔,降低骨强度和导致骨折风险增加的疾病。骨质疏松症最常见的骨折部位是手腕、脊椎、肩部和髋部。骨质疏松症可以在任何年龄发作,但它主要影响绝经后妇女,因为她们形成新骨的能力不能平衡骨吸收的速度。2,3这种骨丢失随着时间的推移导致骨骼变弱,增加了骨折的可能性。2 在她们的一生中,至少三分之一的女性和五分之一的男性会患上骨质疏松症。骨质疏松症的骨折比心脏病、中风和乳腺癌合并更常见。每三个髋关节骨折的人中就有一个会在一年内再次骨折,每两个人中就有一个会在五年内再骨折。2 世界卫生组织已正式宣布骨质疏松为公共卫生危机,而国际骨质疏松症基金会则敦促世界各国政府将骨质疏松症列为卫生保健的优先事项。7 关于加拿大安进(Amgen) 作为创新的领导者,安进(Amgen)加拿大理解科学的价值。其主要业务位于 Ont 的 Mississauga 。自1991年以来,加拿大安进(Amgen)公司在加拿大 Burnaby , B.C .的生物医学集群及其研究机构一直是加拿大科学和创新进步的重要贡献者。公司与加拿大许多领先的医疗保健、学术、研究、政府和患者组织合作,为现有药物开发新疗法和新用途做出贡献。要了解更多关于加拿大安进(Amgen)的信息,请访问 www.amgen.ca 。 安进(Amgen)前瞻声明 本新闻稿包含前瞻性的声明,是基于目前的预期和信仰安进(Amgen)。除历史事实陈述外,所有陈述均可视为前瞻性陈述,包括收入估计、营业利润率、资本支出、现金、其他财务指标、预期法律、仲裁、政治、监管或临床结果或实践、客户和处方者模式或实践,偿还活动和结果以及其他此类估计和结果。前瞻性陈述涉及重大风险及不明朗因素,包括下文所讨论及安进(Amgen)提交的证券及交易委员会报告更全面描述的风险及不明朗因素,包括其最近10-K 表格的年度报告及10-Q 表格的任何后续定期报告及8-K 表格的当前报告。除非另有说明,安进(Amgen)公司在本新闻稿发布之日提供该信息,并不承担任何义务更新本文件中包含的任何前瞻性声明,因为新信息、未来事件或其他原因。 不能保证前瞻性声明,实际结果可能与安进(Amgen)项目有重大差异。发现或鉴定新产品的候选者或开发现有产品的新适应症是不能保证的,从概念到产品的转移是不确定的;因此,不能保证任何特定的产品候选者或现有产品的新适应症的开发成功并成为商业产品。此外,临床前结果并不能保证产品在人体内的安全性和有效性。人体的复杂性不可能是完美的,或者有时甚至不能由计算机或细胞培养系统或动物模型充分模拟。安进完成临床试验并获得产品上市的监管批准所需的时间在过去是变化的,安进(Amgen)预计未来也会有类似的变化。即使临床试验成功,监管部门也可能质疑安进(Amgen)选择的试验终点是否足够。安进(Amgen)在内部开发产品候选人,并通过许可合作、合作和合资企业。来自关系的产品候选者可能会受到双方之间的争议,或者可能证明不像安进(Amgen)在建立关系时所相信的那样有效或安全。此外,安进(Amgen)或其他公司可以确定其产品(包括其设备)上市后的安全性、副作用或制造问题。 安进(Amgen)的业绩可能受到其在国内外成功销售新产品和现有产品的能力、涉及当前和未来产品的临床和监管发展、近期推出产品的销售增长、来自包括生物仿制药在内的其他产品的竞争在制造其产品和全球经济状况方面的困难或延误。此外,安进(Amgen)产品的销售受到定价压力、政治和公共审查以及第三方付款人(包括政府、私人保险计划和托管护理提供商)强加的报销政策的影响,并可能受到监管部门的影响。临床和指南的发展以及国内和国际管理保健和保健费用控制趋势。此外,安进(Amgen)的研究、测试、定价、营销等业务受到国内外政府监管部门的广泛监管。安进的业务可能受到政府调查、诉讼和产品责任索赔的影响。此外,安进(Amgen)的业务可能受到通过新税法或承担额外税务责任的影响。虽然安进公司经常获得其产品和技术的专利,但其专利和专利申请提供的保护可能会受到竞争对手的质疑、无效或规避,或者安进(Amgen)公司在目前和未来的知识产权诉讼中可能无法胜诉。安进(Amgen)在包括波多黎各在内的几个关键制造设施从事大量的商业制造活动,其部分制造活动还依赖第三方,对供应的限制可能限制其某些现有产品的销售和产品候选开发。我们依靠与第三方的合作来开发我们的一些产品候选者,以及我们的一些商业产品的商业化和销售。此外,安进(Amgen)在许多营销产品以及新产品的发现和开发方面与其他公司竞争。此外,安进(Amgen)产品的部分原材料、医疗器械及零部件由独家第三方供应商供应。安进的某些经销商、客户和付款人在与安进(Amgen)的交易中有很大的采购杠杆。发现与安进(Amgen)产品类似的产品存在重大问题,涉及整个产品类别,可能对受影响产品的销售及其业务和经营成果产生重大不利影响。安进收购其他公司或产品以及整合安进(Amgen)收购的公司运营的努力可能不会成功。故障、网络攻击或信息安全漏洞可能会损害安进(Amgen)系统和安进数据的保密性、完整性和可用性。安进(Amgen)的股价可能会波动,可能会受到一些事件的影响。安进公司的经营业绩可能影响或限制安进(Amgen)公司董事会宣布股息或其支付股息或回购普通股的能力。安进(Amgen)可能无法以对其有利的条件进入资本和信贷市场,或者根本无法进入。 参考文献 EVENITY ™产品专著。安进(Amgen)加拿大公司(2019年6月)。 加拿大骨质疏松症。骨质疏松症的事实和统计.https://骨质疏松症。ca / about-disease / fast-facts / accessed June 19,2019。 国际骨质疏松症基金会.骨质疏松症的全球负担:一个概况。网址: https://iofboneheath 。org / sites / default / files / media / PDF / Fact %20Sheets /2014-factsheet-protesheet-bonoss-A4。pdf 。截止2019年6月19日。 罗索单抗治疗绝经后妇女骨质疏松症( FRAME )的疗效和安全性。可在: https://临床 altrials 。gov / ct2/ show / NCT01575834?术语= NCT01575834,秩=1。截止2019年6月5日。 罗莫索珠单抗治疗绝经后妇女骨质疏松疗效及安全性的研究。可在: https://临床 altrials 。gov / ct2/ show / NCT01631214?期限= NCT01631214&秩=1。截止2019年6月5日。 世界卫生组织.世界卫生组织公报.运动干预:解除世界骨质疏松定时炸弹.http://www.who.int/bulletin/volume/81/11/mingchanwa1103。pdf 。到2019年4月。 国际骨质疏松症基金会.全球倡议.http://www.iofboneheath.org/global-initiative-0。到2019年4月。 加拿大南部安进(Amgen)

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