Bagsværd, Denmark, 21 March 2024 – Novo Nordisk today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending marketing authorisation for Awiqli® (the brand name for once-weekly basal insulin icodec) for treatment of diabetes in adults.

丹麦Bagsværd，2024年3月21日–诺和诺德今天宣布，欧洲药品管理局人类使用药品委员会（CHMP）已采纳积极意见，建议批准Awiqli®（每周一次基础胰岛素icodec的品牌名称）用于治疗成人糖尿病。

The positive CHMP opinion is based on results from the ONWARDS phase 3a clinical trial programme. Once-weekly basal insulin icodec achieved superior blood sugar reduction1 (measured by a change in HbA1c) and superior Time in Range2 (time spent within recommended blood sugar range), compared with daily basal insulin in people with type 2 diabetes.

CHMP的积极意见是基于3a期临床试验计划的结果。与2型糖尿病患者的每日基础胰岛素相比，每周一次的基础胰岛素icodec可以实现更好的血糖降低1（通过HbA1c的变化来衡量）和更好的时间范围2（在推荐的血糖范围内花费的时间）。

In people with type 2 diabetes who have not previously been treated with insulin, overall observed rates of clinically significant or severe hypoglycaemia3 were below one event per patient-year of exposure with both once-weekly basal insulin icodec and comparators. In people with type 1 diabetes, once-weekly basal insulin icodec demonstrated non-inferiority in reducing HbA1c with a statistically significant higher estimated rate of severe or clinically significant hypoglycaemia compared with insulin degludec4.

在以前没有接受过胰岛素治疗的2型糖尿病患者中，每周一次的基础胰岛素icodec和对照组的临床显着或严重低血糖3的总体观察率低于每患者年暴露一次事件。在1型糖尿病患者中，每周一次的基础胰岛素icodec在降低HbA1c方面表现出非劣效性，与胰岛素degludec4相比，严重或临床显着低血糖的估计发生率在统计学上显着更高。

Across the programme, once-weekly basal insulin icodec appeared to have a safe and well-tolerated profile. “We believe that by reducing the number of basal insulin injections from seven to one per week, Awiqli® has the potential to have a significant impact and improve treatment for people living with diabetes,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk.

在整个计划中，每周一次的基础胰岛素icodec似乎具有安全且耐受性良好的特征。诺和诺德发展执行副总裁Martin Holst Lange表示：“我们认为，通过将基础胰岛素注射次数从每周七次减少到一次，Awiqli®有可能对糖尿病患者产生重大影响并改善治疗。”

“We are committed to driving innovation in diabetes treatment, and Awiqli® has the potential to become the insulin of choice for people with type 2 diabetes initiating insulin treatment.” Novo Nordisk expects to.

“我们致力于推动糖尿病治疗的创新，Awiqli®有可能成为2型糖尿病患者开始胰岛素治疗的首选胰岛素。”诺和诺德预计。