Nplate® Now Approved For Earlier Use In Adults With Immune Thrombocytopenia

Nplate获FDA批准用于成人免疫性血小板减少症

2019-10-21 16:30:28 CISION

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Amgen today announced that the U.S. Food and Drug Administration approved Amgen's Supplemental Biologics License Application for Nplate® to include new data in its U.S. prescribing information showing sustained platelet responses in adults with immune thrombocytopenia , a rare, serious autoimmune disease characterized by low platelet counts. The updated indication expands treatment with Nplate to newly diagnosed and persistent adult ITP patients who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. In December of last year, the FDA approved another sBLA for Nplate in the treatment of pediatric patients with ITP. "These new data are the first of their kind to prospectively examine treatment-free remission as an outcome for patients with ITP. Thirty-two percent of patients who received Nplate soon after an insufficient response to the first course of steroids maintained platelet response for at least six months without Nplate or any other ITP therapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "This approval will provide patients the opportunity to receive Nplate earlier in the course of their disease, potentially reducing their need for prolonged steroid use. We are excited to make Nplate available to more patients with this rare blood disorder." The sBLA was based on an open-label, single-arm Phase 2 trial of adults with ITP diagnosed ≤ 6 months prior who had an insufficient response to first-line treatment, including corticosteroids (N=75). The median time from ITP diagnosis to study enrollment was 2.2 months. On the primary endpoint, the median number of months with platelet response (≥ 50 x 109/L) was 11 months during the 12-month treatment period (95% CI: 10, 11), with a median time to first platelet response of 2.1 weeks (95% CI: 1.1, 3.0). Additionally, 93% (70) of patients achieved one or more platelet responses during the 12-month treatment period. On the secondary endpoint, 32% (24) of patients achieved remission for at least six months, defined by maintaining a platelet count ≥ 50 x 109/L in the absence of Nplate and any medication for ITP (concomitant or rescue). "Among adults with immune thrombocytopenia, there is a need for treatment options that can get patients to sustained remission," said Caroline Kruse, president and chief executive officer, Platelet Disorder Support Association. "The addition of this new data will help physicians and patients communicate and weigh the benefits and risks of treatment to find an appropriate treatment choice." The safety profile of Nplate was similar across patients, regardless of ITP duration. The following adverse reactions (at least 5% incidence and at least 5% more frequent with Nplate compared with placebo or standard of care) occurred in Nplate patients with ITP duration up to 12 months: bronchitis, sinusitis, vomiting, arthralgia, myalgia, headache, dizziness, diarrhea, upper respiratory tract infection, cough, nausea and oropharyngeal pain. The adverse reaction of thrombocytosis occurred with an incidence of 2% in adults with ITP duration up to 12 months. About the Phase 2 StudyThe Phase 2 study was a single-arm, open-label study designed to assess the safety and efficacy of Nplate in adult patients who had an insufficient response (platelet count ≤ 30 x 109/L) to first line therapy (N=75). The median time from ITP diagnosis to study enrollment was 2.2 months. Prior ITP treatments included corticosteroids, immunoglobulins and anti-D immunoglobulins. Rescue therapies were permitted. Patients received single weekly SC injections of Nplate over a 12-month treatment period, with individual dose adjustments to maintain platelet counts (50 x 109/L to 200 x 109/L).  About Immune Thrombocytopenia (ITP)ITP is a rare, serious autoimmune disease characterized by low platelet counts in the blood (a condition known as thrombocytopenia) and impaired platelet production.1 In the U.S., the estimated incidence of ITP is 6.1 per 100,000 adults annually.2 Nearly 20,000 people are newly diagnosed with ITP each year in the U.S.2 About Nplate® (romiplostim)Nplate is a thrombopoietin (TPO) receptor agonist that mimics the body's natural TPO and is designed to increase platelet counts in patients with ITP.3  In the U.S: Nplate is approved for the treatment of thrombocytopenia in adult patients with ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate is approved for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. In the European Union (EU): Nplate is approved for the treatment of chronic ITP in adults and in children age one year and older with ITP for at least six months, who have had an insufficient response to other medicines or had surgery to remove the spleen. Nplate is also approved in 69 countries, including Canada and Australia. For more information about Nplate, please visit www.Nplate.com. IMPORTANT SAFETY INFORMATION Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia In Nplate® (romiplostim) clinical trials of patients with myelodysplastic syndromes (MDS) and severe thrombocytopenia, progression from MDS to acute myelogenous leukemia (AML) has been observed. Nplate® is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than ITP. Thrombotic/Thromboembolic Complications Thrombotic/thromboembolic complications may result from increases in platelet counts with Nplate® use. Portal vein thrombosis has been reported in patients with chronic liver disease receiving Nplate®. To minimize the risk for thrombotic/thromboembolic complications, do not use Nplate® in an attempt to normalize platelet counts. Follow the dose adjustment guidelines to achieve and maintain a platelet count of ≥ 50 x 109/L. Loss of Response to Nplate® Hyporesponsiveness or failure to maintain a platelet response with Nplate® should prompt a search for causative factors, including neutralizing antibodies to Nplate®. To detect antibody formation, submit blood samples to Amgen (1‑800‑772‑6436). Amgen will assay these samples for antibodies to Nplate® and thrombopoietin (TPO). Discontinue Nplate® if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at the highest weekly dose of 10 mcg/kg. Adverse Reactions Adult ITP In the placebo-controlled trials of adult ITP patients, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate® and 32% of patients receiving placebo. Adverse drug reactions in adults with a ≥ 5% higher patient incidence in Nplate® versus placebo were Arthralgia (26%, 20%), Dizziness (17%, 0%), Insomnia (16%, 7%), Myalgia (14%, 2%), Pain in Extremity (13%, 5%), Abdominal Pain (11%, 0%), Shoulder Pain (8%, 0%), Dyspepsia (7%, 0%), and Paresthesia (6%, 0%). The safety profile of Nplate was similar across patients, regardless of ITP duration. The following adverse reactions (at least 5% incidence and at least 5% more frequent with Nplate compared with placebo or standard of care) occurred in Nplate patients with ITP duration up to 12 months: bronchitis, sinusitis, vomiting, arthralgia, myalgia, headache, dizziness, diarrhea, upper respiratory tract infection, cough, nausea and oropharyngeal pain. The adverse reaction of thrombocytosis occurred with an incidence of 2% in adults with ITP duration up to 12 months. Pediatric ITP The most common adverse reactions experienced by ≥ 5% of patients receiving Nplate with > 5% higher incidence in the romiplostim arm across the two placebo-controlled trials were contusion (41%), upper respiratory tract infection (31%), oropharyngeal pain (25%), pyrexia (24%), diarrhea (20%), rash (15%), and upper abdominal pain (14%). In pediatric patients of age > 1 year receiving romiplostim for ITP, adverse reactions with an incidence of > 25% in the two randomized trials were: contusion (41%), upper respiratory tract infection (31%), and oropharyngeal pain (25%). Nplate® administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of Nplate®. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate® therapy. INDICATIONSNplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate® is indicated for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP.  Nplate® should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.  Nplate® should not be used in an attempt to normalize platelet counts. Please see full Prescribing Information and Medication Guide. 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安进公司今天宣布,美国食品药品监督管理局(Food and Drug Administration)批准了安进(Amgen)公司的补充生物技术许可证申请 Nplate ®包括其美国处方信息中的新数据,该信息显示成人免疫血小板减少症(一种罕见的严重自身免疫性疾病,其特点是血小板计数低)。更新的适应症扩大治疗 Nplate ,以新诊断和持续存在的成人 ITP 患者谁对皮质激素,免疫球蛋白或脾切除术反应不足。去年12月, FDA 批准了另一种用于 Nplate 治疗小儿 ITP 患者的 sBLA 。 “这些新的数据是他们首次前瞻性地将无治疗缓解作为 ITP 患者的结果。在第一个疗程类固醇反应不足后不久接受 Nplate 治疗的患者中,32%在没有 Nplate 或任何其他 ITP 治疗的情况下维持血小板反应至少6个月。“这一批准将为患者提供在疾病早期接受 Nplate 的机会,可能减少他们长期使用类固醇的需要。我们很高兴能为更多的这种罕见的血液病患者提供 Nplate 。” sBLA 是基于开放标签,单臂第二期试验的成人 ITP 诊断≤6个月前谁对一线治疗反应不足,包括皮质类固醇( N =75)。从 ITP 诊断到参加研究的平均时间为2.2个月。在主要终点,12个月治疗期间血小板应答的中位数(≥50 x 109/ L )为11个月(95% CI :10,11),第一次血小板应答的中位数为2.1周(95% CI :1.1,3.0)。此外,93%(70%)的患者在12个月的治疗期间达到一个或多个血小板反应。在第二终点,32%(24)的患者达到缓解至少6个月,定义是维持血小板计数≥50×109/ L 在没有 Nplate 和任何药物治疗 ITP (伴随或抢救)。 血小板紊乱支持协会主席兼首席执行官卡罗琳·克鲁斯说:“在患有免疫性血小板减少症的成年人中,有必要选择治疗方案,使患者能够持续缓解。”“新数据的加入将有助于医生和患者沟通和权衡治疗的益处和风险,找到合适的治疗选择。” 无论 ITP 持续时间长短, Nplate 的安全性在所有患者中都是相似的。以下不良反应(与安慰剂或护理标准相比, Nplate 的发生率至少为5%,与 Nplate 的发生率至少为5%)发生在 ITP 持续时间长达12个月的 Nplate 患者:支气管炎、鼻窦炎、呕吐、关节痛、肌痛、头痛、头晕、腹泻、上呼吸道感染、咳嗽、恶心和口咽疼痛。血小板增生症的不良反应发生在12个月内,成人 ITP 发生率为2%。 第二阶段研究第二阶段研究是一项单臂开放标签研究,旨在评估 Nplate 对一线治疗反应不足(血小板计数≤30×109/ L )的成人患者的安全性和有效性( N =75)。从 ITP 诊断到参加研究的平均时间为2.2个月。以前的 ITP 治疗包括皮质激素、免疫球蛋白和抗 D 免疫球蛋白。救援治疗是允许的.患者接受为期12个月的单周 SC 注射 Nplate ,每次剂量调整以维持血小板计数(50 x 109/ L 至200 x 109/ L )。 关于免疫血小板减少症( ITP ) ITP 是一种罕见的、严重的自身免疫性疾病,其特点是血液中血小板计数低(血小板减少症)和血小板生成受损。1在美国,估计每年每10万成年人 ITP 的发病率为6.1。美国每年有近2万人被诊断为 ITP 关于 Nplate ®( romylostim ) Nplate 是一种血小板生成素( TPO )受体激动剂,它模仿人体的自然 TPO ,旨在增加 ITP 患者的血小板数量。3. 在美国。S : Nplate 被批准用于治疗对皮质激素、免疫球蛋白或脾切除术反应不足的 ITP 成人血小板减少症。 Nplate 被批准用于治疗儿童血小板减少症患者1岁及以上的 ITP 患者至少6个月,他们对皮质激素、免疫球蛋白或脾切除术反应不足。 在欧洲联盟(欧盟): Nplate 被批准用于治疗成人和一岁及一岁以上的儿童, ITP 患者至少6个月,他们对其他药物反应不足或进行了切除脾脏的手术。 Nplate 还在加拿大和澳大利亚等69个国家获得批准。 有关 Nplate 的详细信息,请访问 www.Nplate.com 。 重要的安全资料 骨髓增生异常综合征发生急性髓性白血病的风险 在 Nplate ®( romylostim )临床试验中,观察到骨髓增生异常综合征( MDS )和严重血小板减少症患者从 MDS 进展为急性髓系白血病( AML )。 Nplate ®不适用于治疗 MDS 引起的血小板减少症或 ITP 以外的血小板减少症。 血栓/血栓栓塞并发症 血小板计数增加使用 Nplate ®可能导致血栓/血栓栓塞并发症。门静脉血栓已报告慢性肝病患者接受 Nplate ®。 为了尽量减少血栓/血栓栓塞并发症的风险,请不要使用 Nplate ®来试图使血小板计数正常化。按照剂量调整指导原则,实现并保持血小板计数≥50×109/ L 。 Nplate ®响应损失 使用 Nplate ®维持血小板反应的低反应性或失败应促使寻找导致因素,包括对 Nplate ®的中和抗体。 为了检测抗体的形成,将血液样本送到安进(Amgen)(1-800-772-6436)。安进(Amgen)公司将检测这些样本是否含有 Nplate ®和血小板生成素( TPO )抗体。 停用 Nplate ®如果血小板计数没有增加到足以避免4周后临床上重要出血的水平,每周最高剂量为10微克/千克。 不良反应 成人 ITP 在成年 ITP 患者的安慰剂对照试验中,头痛是最常见的不良反应,发生在35%接受 Nplate ®的患者和32%接受安慰剂的患者。Nplate ®与安慰剂相比,成人不良反应发生率≥5%的患者为 Arthralgia (26%、20%)、 Dizzy (17%、0%)、 Insomnia (16%、7%)、 Myalga (14%、2%)、 Extremity 疼痛(13%、5%)、 Abroll 疼痛(11%、0%)、肩痛(8%、0%)、消化不良(7%、0%)和感觉异常(6%、0%)。 无论 ITP 持续时间长短, Nplate 的安全性在所有患者中都是相似的。以下不良反应(与安慰剂或护理标准相比, Nplate 的发生率至少为5%,与 Nplate 的发生率至少为5%)发生在 ITP 持续时间长达12个月的 Nplate 患者:支气管炎、鼻窦炎、呕吐、关节痛、肌痛、头痛、头晕、腹泻、上呼吸道感染、咳嗽、恶心和口咽疼痛。血小板增生症的不良反应发生在12个月内,成人 ITP 发生率为2%。 小儿 ITP 在接受 Nplate 治疗的患者中,超过5%的患者在两个安慰剂对照的试验中出现的最常见的不良反应是挫伤(41%)、上呼吸道感染(31%)、口咽疼痛(25%)、发热(24%)、腹泻(20%)、皮疹(15%)和上腹痛(14%)。 在年龄大于1岁的小儿 ITP 患者中,两项随机试验的不良反应发生率>25%,分别为:挫伤(41%)、上呼吸道感染(31%)和口咽疼痛(25%)。 Nplate ®给药可能会增加骨髓中网状纤维形成的风险。当 Nplate ®中断时,这种形成可能会改善。在一项临床试验中,一名 ITP 患者和溶血性贫血患者在 Nplate ®治疗期间出现了带胶原的骨髓纤维化。 INTIONSNplate ®是一种血小板生成素受体激动剂,用于治疗免疫血小板减少症( ITP )成人患者的血小板减少,这些患者对皮质激素、免疫球蛋白或脾脏切除反应不足。Nplate ®用于治疗1岁及以上 ITP 患者的血小板减少症,这些患者至少6个月来对皮质激素、免疫球蛋白或脾切除术反应不足。 Nplate ®不适用于治疗骨髓增生异常综合征( MDS )或 ITP 以外的血小板减少症。Nplate ®仅适用于血小板减少程度和临床状况增加出血风险的 ITP 患者。Nplate ®不应用于使血小板计数标准化。 请参阅完整的处方信息和药物指南。 关于安进肿瘤学安进(Amgen)正在寻找和寻找解决难以置信的复杂问题,将促进护理和改善癌症患者及其家庭的生活。我们的研究促使我们在病人生命的背景下理解疾病,而不仅仅是癌症的旅程,这样他们就能控制自己的生命。 在过去的四十年里,我们一直致力于发现肿瘤学中最重要的问题,并寻找减少癌症负担的方法。基于我们的传统,安进(Amgen)公司将继续推进公司历史上最大的管道建设,以更快的速度为需要的患者推进这些创新。 在安进(Amgen),我们的目标是改变癌症患者的生活,使他们成为我们所做一切的中心。 有关更多信息,请访问 www.twitter.com / amgenomics 。 关于 AmgenAmgen 致力于通过发现、开发、制造和提供创新的人类疗法,为患有严重疾病的患者释放生物学的潜力。这种方法首先使用先进的人类遗传学工具来解决疾病的复杂性,并理解人类生物学的基本原理。 安进(Amgen)专注于高未得到满足的医疗需求领域,并利用其专业知识努力寻求改善健康结果和显著改善人们生活的解决方案。安进(Amgen)是自1980年以来的生物技术先锋,现已发展成为世界领先的独立生物技术公司之一,已接触到世界各地的数百万患者,并正在开发一系列具有分离潜力的药物。 有关更多信息,请访问:\160; www.amgen.com ,并在\160; www.twitter.com / amgen 上跟随我们。 前瞻性陈述本新闻稿包含前瞻性陈述,这些陈述基于安进(Amgen)目前的预期和信念。除历史事实陈述外,所有陈述均可视为前瞻性陈述,包括关于收购 Otezla ®( apremiplate )的结果、收益和协同效应的任何陈述,包括预期的 Otezla 销售增长和非非一般公认会计原则(non-GAAP)每股收益增长的时间以及收入估计。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、监管或临床结果或做法、客户和开处方者模式或做法、报销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,包括我们最近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,实际结果可能与我们预计的结果有重大差异。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。我们完成临床试验并获得产品营销的监管批准所需的时间在过去是变化的,我们预计未来也会有类似的变化。即使临床试验成功,监管部门也可能会质疑我们选择的试验终点是否足够。我们在内部通过许可合作、合作伙伴关系和合资企业开发产品候选人。来自关系的产品候选人可能会受到双方之间的争议,或者可能证明不像我们在建立这种关系时所相信的那样有效或安全。此外,我们或其他人可以确定我们的产品,包括我们的设备,上市后的安全,副作用或制造问题。 我们的业绩可能受到以下因素的影响:我们成功地在国内和国际上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法规开发,最近推出的产品的销售增长,来自包括生物仿制药在内的其他产品的竞争。我们产品制造的困难或延误以及全球经济状况。此外,我们的产品销售受到定价压力、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,我们的研究、测试、定价、营销和其他业务受到国内外政府监管部门的广泛监管。我们的业务可能受到政府调查、诉讼及产品责任申索的影响。此外,我们的业务可能受到新税务法例的采纳或承担额外税务责任的影响。如果我们未能履行我们与美国政府之间的企业诚信协议中的合规义务,我们可能会受到重大制裁。此外,当我们经常就产品及技术取得专利时,我们的专利及专利申请所提供的保护可能会受到竞争对手的质疑、失效或规避,或我们可能在目前及未来的知识产权诉讼中未能胜诉。我们在一些关键设施(包括波多黎各)进行大量商业制造活动,并在部分制造活动中依赖第三方,而对供应的限制可能会限制我们目前某些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,我们与其他公司就我们的许多营销产品以及新产品的发现和开发进行竞争。此外,我们产品的部分原材料、医疗器械及部件由独家第三方供应商供应。我们的若干分销商、客户及付款人在与我们的交易中拥有重大的采购杠杆。发现与涉及整个产品类别的产品类似的产品的重大问题,可能会对受影响产品的销售、业务及经营业绩造成重大不利影响。我们收购其他公司或产品以及整合我们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我们系统和数据的保密性、完整性和可用性。我们的股票价格是波动的,可能会受到一些事件的影响。我们的业务表现可能影响或限制董事会宣派股息的能力或我们支付股息或购回我们普通股的能力。我们可能无法以对我们有利的条件进入资本和信贷市场,或者根本无法进入。 联系人:安进(Amgen), OaksTrish Hawkins ,805-447-5631( Media ) Jessica Akopyan ,805-447-0974( Media ) Arvind Sood ,805-447-1060( Investors ) 参考文献 苏丹安进(Amgen) http://www.amgen.com 你刚才读到:

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