Novo Nordisk's Haemophilia A Drug Esperoct Gets EU Approval


2019-06-24 19:05:00 Zacks


Novo Nordisk A/S NVO announced that the European Commission has granted marketing authorization for Esperoct for the treatment of adolescents and adults with haemophilia A. The authorization covers all 28 European Union member states. Novo Nordisk expects to launch Esperoct in the first European countries during the second half of 2019. Esperoct is the brand name for turoctocog alfa pegol, N8-GP. The efficacy and safety evaluation was based on the results from the largest pre-registration clinical program conducted in haemophilia A, with inclusion of 270 previously treated people (PTPs) with severe haemophilia A and more than 5 years of clinical exposure. Esperoct has been found effective in treating severe haemophilia A through a simple fixed dosing regimen of one injection every four days in adults and adolescents or every 3-4 days (twice-weekly) in children. The drug is also found to be effective in controlling bleeding episodes and perioperative management with no acute safety concerns. The marketing authorization for the use of Esperoct treads on the heels of the positive opinion given by the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in April 2019. Shares of Novo Nordisk have increased 12.2% year to date compared with the industry’s 7.8% growth. In February 2019, Novo Nordisk announced the FDA’s approval of its biologics license application (BLA) for Esperoct to treat adults and children with haemophilia A. In the United States, Esperoct is indicated for use in adults and minors with haemophilia A — using routine prophylaxis — to reduce bleeding episode frequency as well as on-demand for controlling bleeding episodes and the perioperative management of bleeding. The marketing authorization for Esperoct in Europe will further lead to increased sales of the drug. The company is making efforts to develop new treatments for diabetes, which is its core area of expertise. In January 2019, Novo Nordisk initiated a phase I study on LAIsema, the combination of once-weekly insulin LAI287 and once-weekly injectable GLP-1 semaglutide. The study will investigate single-dose pharmacokinetics of LAIsema in a fixed ratio compared with LAI287 and semaglutide given separately to people with type II diabetes. In November 2018, Novo Nordisk completed the extension phase of REAL 3, the phase II study with long-acting recombinant growth hormone, somapacitan (NN8640) for treatment of growth hormone deficiency (GHD). The company is preparing for the pivotal phase III somapacitan programs in children with GHD and a phase II study in children born small for gestational age (SGA).
诺和诺德(Novo Nordisk) A / S NVO 宣布,欧盟委员会已批准 Esperoct 公司治疗 A 型血友病的青少年和成年人。该授权涵盖了欧盟所有28个成员国。诺和诺德(Novo Nordisk)预计将在2019年下半年在第一批欧洲国家推出 Esperoct 。 Esperoct 是 Turoctoog alfa 聚乙二醇的品牌名称, N8-GP 。疗效和安全性评价基于在血友病 A 中进行的最大的注册前临床方案的结果,包括270名先前接受过治疗的严重血友病 A 患者和5年以上的临床暴露。 在成人和青少年中,或在儿童中每3-4天(每周两次)使用一次注射的简单固定剂量方案,可以有效地治疗严重的血友病 A 。该药物还被发现有效控制出血发作和围手术期管理没有急性安全问题。 在欧洲药品管理局( EMA )下属的人类用药品委员会( CHMP )于2019年4月发表积极意见后, Esperoct 踏板的使用获得了上市许可。 诺和诺德(Novo Nordisk)的股价今年迄今已上涨12.2%,而该行业的涨幅为7.8%。 2019年2月,诺和诺德(Novo Nordisk)宣布 FDA 批准 Esperoct 的生物制剂许可申请( BLA ),用于治疗成人和儿童血友病 A 。Esperoct 可用于成人和未成年人血友病 A -使用常规预防-以减少出血的发作频率,并按需控制出血发作和围手术期管理出血。 Esperoct 在欧洲的市场授权将进一步导致该药物的销售增加。 该公司正在努力开发新的糖尿病治疗方法,这是其核心专业领域。2019年1月,诺和诺德(Novo Nordisk)启动了 LAIsema 的 I 期研究,即每周一次的 LAI287胰岛素和每周一次的注射 GLP-1精氨酸。这项研究将研究 LAIsema 的单剂量药代动力学与分别给予2型糖尿病患者的 LAI287和 semaglutide 的固定比例。 2018年11月,诺和诺德(Novo Nordisk)完成 REAL 3的扩展期阶段,二期研究用长效重组生长激素、生长抑素( NNN8640)治疗生长激素缺乏症( GHD )。公司正在筹备 GHD 儿童的 III 期体细胞清扫剂重点项目和孕龄小的儿童的 II 期研究( SGA )。