美国食品药品监管局批准首款用于儿童的每周一次胰岛素：Awiqli适用10岁及以上2型糖尿病患者
新泽西州 Plainsboro——Novo Nordisk 公司10月23日宣布，美国食品药品监管局（FDA）已批准其 Awiqli（insulin icodec-abae）注射液 700 units/mL 用于10岁及以上患有2型糖尿病的儿童，作为饮食与运动的辅助手段改善血糖控制。Awiqli 是首款每周注射一次的长效基础胰岛素，本次批准把它的适用人群由成人扩展到儿童，基础胰岛素注射频率由每周七次降为每周一次。FDA 当天也在其药品动态索引中列出了这一批准：首款用于儿童2型糖尿病患者的每周一次胰岛素。
Novo Nordisk 执行医疗总监 Michael Radin 说，2型糖尿病患者及其家庭一直在寻找能让治疗更个体化的选择，Awiqli 把基础胰岛素注射从每周七次减到一次，可能帮助患者找到更容易坚持的用药节奏。加州大学旧金山分校儿科学教授 Eda Cengiz 说，儿童2型糖尿病病程进展较快、持续控制血糖一直是难题，每周一次的基础胰岛素为儿科临床提供了新的替代选择，有望减少每日注射带来的负担。
公司表示，本次批准的依据包括在成人2型糖尿病患者中完成的充分且对照良好的研究，以及一项在10岁至18岁以下儿童患者中完成的单剂量药代动力学研究，其结果与关键性 ONWARDS 临床试验项目证明的疗效与安全性共同支持在10岁及以上儿童中使用。Awiqli 使用 FlexTouch 预填充笔、每周在同一天注射一次，目前在全美7万多家药房有售；该药已在美国、欧盟及另外18个国家获批。
公司同时公布了用药安全信息：Awiqli 常见副作用包括低血糖、严重过敏反应、注射部位反应、注射部位皮肤增厚或凹陷、瘙痒、皮疹、手脚肿胀与体重增加；正在发生低血糖或对该药过敏的人不应使用，10岁以下儿童中的安全性与有效性尚未确定。公司援引一项模型研究称，美国19岁及以下人群中2型糖尿病患者人数预计到2050年将接近8.4万人。
来源：GSM·美国
FDA Approves Awiqli, the First Once-Weekly Insulin for Children 10 and Older With Type 2 Diabetes
PLAINSBORO, New Jersey — Novo Nordisk announced on October 23 that the U.S. Food and Drug Administration (FDA) has approved Awiqli (insulin icodec-abae) injection 700 units/mL to improve glycemic control, as an adjunct to diet and exercise, in children 10 years of age and older with type 2 diabetes. Awiqli is the first once-weekly, long-acting basal insulin, and the approval extends its use from adults to pediatric patients, reducing basal insulin injections from seven times a week to one. The FDA also listed the approval in its drug news index the same day as the first once-weekly insulin for type 2 diabetes in pediatric patients.
Michael Radin, executive medical director at Novo, said individuals with type 2 diabetes and their families seek treatment options that may allow for more individualized care, and that reducing basal injections from seven to one per week may help patients find a routine that feels more manageable. Eda Cengiz, Professor of Pediatrics at the University of California, San Francisco, said children with type 2 diabetes face an aggressive disease trajectory and that an FDA-approved once-weekly basal insulin could provide new alternatives for pediatric care and help reduce administration barriers.
The company said the approval is supported by adequate and well-controlled studies in adults with type 2 diabetes and a single-dose pharmacokinetic study in pediatric patients aged 10 to under 18, together with the efficacy and safety demonstrated in the pivotal ONWARDS clinical trial program. Awiqli is given once a week, on the same day each week, using the FlexTouch pen, is available at more than 70,000 pharmacies nationwide, and is approved in the United States, the European Union and 18 additional countries.
The company also released safety information: common side effects may include hypoglycemia, serious allergic reactions, injection-site reactions, lipodystrophy, itching, rash, swelling of the hands and feet, and weight gain; the drug should not be used during an episode of hypoglycemia or by people allergic to it, and its safety and effectiveness in children under 10 have not been established. Citing a modeling study, the company said the number of people aged 19 and under with type 2 diabetes in the United States is estimated to reach nearly 84,000 by 2050.
Source: GSM · United States
来源：GSM·美国（原文链接）
图片来源：图：胰岛素注射笔使用示意（资料图）。Wikimedia Commons，CC BY-SA 4.0。 / An insulin pen in use (file photo). Via Wikimedia Commons, CC BY-SA 4.0.
