FDA Approves Octapharma’s WILATE® for Hemophilia A in Adult and Adolescent Patients

FDA批准Octapharma的WILATE用于成人和青少年患者的A型血友病

2019-10-09 12:31:36 BioSpace

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This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191008005749/en/ Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved WILATE® for treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes. (Photo: Business Wire) WILATE® is a human plasma-derived, sterile, purified, double virus inactivated von Willebrand Factor (VWF)/coagulation Factor VIII (FVIII) complex initially approved by the FDA in 2009 for children and adults with von Willebrand Disease (VWD) for on-demand treatment and control of bleeding episodes; and perioperative management of bleeding. The FDA approved Octapharma’s application to add the hemophilia A indication based on the results of the “Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A,” (ClinicalTrials.gov Identifier: NCT02954575). “Octapharma has been committed to providing U.S. hemophilia A patients with complete access to the company product portfolio since our inception,” said Octapharma USA President Flemming Nielsen. “We are excited for providers and patients who have been looking forward to the day when WILATE® would be indicated for hemophilia A. Octapharma is dedicated to providing the bleeding disorders community with the therapies and programs that enhance patient lives every day.” A total of 136 previously treated patients with hemophilia A (aged 11 to 66 years) received WILATE® in five clinical studies that involved prophylactic use, treatment on demand, surgery and/or pharmacokinetics. All subjects were male. Overall, subjects received 19,317,004 International Units (IU) of WILATE® during 9,001 exposure days. The most common adverse reaction was pyrexia (two subjects; 1.5%). Further adverse reactions included pruritus, headache and sleeping disorder (one subject; 0.75%). Two out of 55 subjects (3.6%) in the pivotal study of routine prophylaxis in severe hemophilia A had unexplained transient worsening of pre-existing thrombocytosis while on the study.1 About WILATE® WILATE®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection, is indicated in children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes; and perioperative management of bleeding. WILATE® is indicated in adolescents and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes; and on-demand treatment and control of bleeding episodes. For complete prescribing information, please visit wilateusa.com. CONTRAINDICATIONS Do not use in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reaction, to human plasma-derived products, any ingredient in the formulation, or components of the container. WARNINGS AND PRECAUTIONS Anaphylaxis and severe hypersensitivity reactions are possible; thromboembolic events may occur; monitor plasma levels of FVIII activity; development of neutralizing antibodies to FVIII and to VWF, especially in VWD type 3 patients, may occur; WILATE® is made from human plasma and carries the risk of transmitting infectious agents. About the Octapharma Group Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines. Octapharma employs approximately 8,314 people worldwide to support the treatment of patients in over 115 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. The company’s American subsidiary, Octapharma USA, is located in Hoboken, N.J. Octapharma operates three state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit www.octapharmausa.com. REFERENCES 1 – Prescribing Information, WILATE®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection, www.wilateusa.com. WIL-0223 Octapharma USA, Inc.• 121 River Street, Suite 1201• Hoboken, NJ 07030 • 201-604-1130 • www.octapharmausa.com View source version on businesswire.com: https://www.businesswire.com/news/home/20191008005749/en/ MEDIA: Anita Callari Yankee Public Relations anita@yankeepr.com 908-425-4878 Source: Octapharma USA Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved WILATE® for treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes. (Photo: Business Wire)   View this news release and multimedia online at: http://www.businesswire.com/news/home/20191008005749/en
美国 Octaphama 今日宣布,美国食品药品监督管理局(Food and Drug Administration)( FDA )已批准 WILATE ®用于治疗成人和青少年血友病 A ,用于常规预防,以减少出血发作的频率,并按需治疗和控制出血发作。(相片:商业电线) WILATE ®是一种人血浆衍生、无菌、纯化、双病毒灭活的 von Willebrand Factor ( VWF )/凝血因子 VIII ( FVIII )复合物,最初于2009年获得 FDA 批准,用于对患有 von Willebrand Disease ( VWD )的儿童和成人进行按需治疗和控制出血发作;以及围手术期管理出血。FDA 批准了 Octapharma 公司的申请,根据“临床研究调查重度血友病 A 患者的蛋白激酶、疗效和 Wilate 安全性”的结果添加血友病 A 适应症(临床试验.gov 标识符: NCT0295575)。 Octaphama 美国总裁弗莱明•尼尔森( Fleming Nielsen )表示:“ Octaphama 自成立以来一直致力于为美国血友病 A 患者提供全面的公司产品组合。”“我们对那些一直期待 WILATE ®能被用于血友病 A 的患者和提供者感到兴奋。 Octaphama 致力于为出血性疾病社区提供每天都能提高患者生活质量的治疗和计划。” 共有136名先前接受治疗的血友病 A 患者(11岁至66岁)接受了 WILATE ®治疗,这五项临床研究涉及预防性使用、按需治疗、手术和/或药物动力学。所有的研究对象都是男性。总体而言,受试者在9,001个暴露日内接受了19,317,004个 WILATE ®国际单位( IU )。最常见的不良反应是发热(2例,1.5%).进一步的不良反应包括瘙痒、头痛和睡眠障碍(一名受试者;0.75%)。在对严重血友病 A 常规预防的关键研究中,55名受试者中有2名(3.6%)在研究期间出现了无法解释的血栓形成前短暂恶化。1 关于 WILATE ® 血管性血友病因子/凝血因子 VIII 复合物(人)静脉注射溶液冻干粉剂®,适用于有血管性血友病病的儿童和成人,用于按需治疗和控制出血发作;围手术期管理出血。WILATE ®适用于青少年和成人血友病 A 患者,用于常规预防,以减少出血发作的频率;以及按需治疗和控制出血发作。完整的处方信息,请访问 wilateusa 。com 。 合约编号 对于已知的过敏症反应,包括过敏或严重系统反应的患者,不要使用人血浆衍生产品、制剂中的任何成分或容器的成分。 警告和警告 过敏反应和严重的过敏症反应是可能的;可能发生血栓栓塞事件;监测血浆中 FVIII 活性水平;可能出现对 FVIII 和 VWF 的中和抗体,特别是在 VWD 类型3患者中; WILATE ®是由人血浆制成,具有传播感染剂的风险。 关于八达法组 Octaphama 公司总部位于瑞士拉琴,是全球最大的人类蛋白质产品制造商之一,自1983年以来一直致力于病人护理和医疗创新。其核心业务是从人类血浆和人类细胞系中开发和生产人类蛋白。Octapharma 在全球雇用约8,314人,支持115多个国家的患者治疗,其产品涵盖以下治疗领域:血液学(凝血障碍)、免疫治疗(免疫障碍)和危重护理。公司美国子公司 Octapharma USA 位于美国新泽西州霍博肯,经营着美国食品药品监督管理局(Food and Drug Administration)( FDA )许可的三个最先进的生产场地,提供了高水平的生产灵活性。如需更多信息,请访问 www.八卦网站。 酬金 1-静脉注射溶液的压榨信息, WILATE ®, von Willebrand Factor /凝血因子 VIII Complex ( Human )冻干粉剂, www.wilateusa.com 。 WIL-0223 Octaphama USA , Inc .•121 River Street , Suite 1201• Hoboken , NJ 07030•201-604-1130• www.Octapharmisa.com 查看 businesswire 上的源代码。http://www.businesswire.com/news/home/2019100085749/en/ MEDIA : Anita Callari 洋基公共关系 anita @ yankepr.com 908-425-4878 资料来源:美国八达法 美国 Octaphama 今日宣布,美国食品药品监督管理局(Food and Drug Administration)( FDA )已批准 WILATE ®用于治疗成人和青少年血友病 A ,用于常规预防,以减少出血发作的频率,并按需治疗和控制出血发作。(相片:商业电线) 浏览本新闻稿及网上多媒体: http://www.businesswire.com/news/home/2019100085749/en

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