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Novo Nordisk’s bid to provide a once-weekly basal insulin product for people with diabetes, reducing the number of injections needed, has hit a major hurdle in the US.The FDA sent the Danish drugmaker a complete response letter (CRL) declining to approve the drug, insulin icodec, saying that it needs more information on its manufacturing process as well as more data on how well it performs in people with type 1 diabetes.In a statement, Novo Nordisk said it was looking into the requirements of the CRL and “ does not expect to be able to fulfil the requests during 2024,” delaying the programme for several months at least.It’s a setback for the company, which has been vying to become the first company to bring a once-weekly basal insulin product to the US market, but comes after insulin icodec has already been approved in the EU, Canada, Australia, Japan, and Switzerland under the Awiqli brand name, as well as in China.Eli Lilly is its nearest rival, developing a once-weekly rival, known as insulin efsitora, which has shown safety and efficacy in two of five ongoing phase 3 trials.Insulin icodec is an insulin analogue that binds strongly to albumin in the blood and reduces its affinity for insulin receptors, effectively creating a reservoir of insulin that gradually releases over time.
诺和诺德(Novo Nordisk)为糖尿病患者提供每周一次的基础胰岛素产品,从而减少所需注射次数,这在美国遇到了一个重大障碍。美国食品和药物管理局(FDA)向丹麦制药商发送了一封完整的回复信(CRL),拒绝批准该药物胰岛素icodec,表示需要更多有关其生产过程的信息,以及有关其在1型糖尿病患者中表现的更多数据。诺和诺德在一份声明中表示,它正在研究CRL的要求,“预计在2024年无法满足要求”,该计划至少推迟了几个月。这对该公司来说是一个挫折,该公司一直在努力成为第一家将每周一次的基础胰岛素产品推向美国市场的公司,但此前胰岛素icodec已在欧盟、加拿大、澳大利亚、日本和瑞士以Awiqli品牌获得批准,以及在中国获得批准。礼来是其最接近的竞争对手,开发了一种每周一次的竞争对手,称为胰岛素efsitora,在正在进行的五项3期试验中,有两项显示出安全性和有效性。胰岛素icodec是一种胰岛素类似物,与血液中的白蛋白强烈结合,降低其对胰岛素受体的亲和力,有效地产生胰岛素储备,随着时间的推移逐渐释放。
It would allow patients with insulin-dependent diabetes to cover their basal insulin needs with one injection per week, as opposed to once or twice daily.Basal insulin helps regulate blood glucose levels throughout the day, while on-demand or ‘bolus’ insulin is used to manage the blood glucose rise that follows meals.The rejection by the FDA has not come as a complete surprise, given that an advisory committee voted by seven to four in May against the use of the drug in type 1 diabetics due .
它将允许胰岛素依赖型糖尿病患者每周注射一次胰岛素来满足其基础胰岛素需求,而不是每天注射一次或两次。基础胰岛素有助于调节全天的血糖水平,而按需或“推注”胰岛素用于控制进餐后的血糖升高。FDA的拒绝并不完全令人惊讶,因为一个咨询委员会在5月以7比4的投票结果反对在1型糖尿病患者中使用该药物。