For Novo Nordisk to gain approval in the United States for its groundbreaking Awiqli (insulin icodec), it will have to first pass muster with a panel of experts next month, according (PDF) to a notice in the Federal Register.The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on May 24 to consider Novo’s application for the injected basal insulin analogue which, if approved, would give Type 1 and Type 2 diabetes patients a once-weekly option.

根据《联邦公报》上的一份公告（PDF），诺和诺德要想在美国获得其开创性的Awiqli（胰岛素icodec）的批准，必须在下个月首先通过专家小组的审查。FDA内分泌和代谢药物咨询委员会将于5月24日召开会议，审议Novo关于注射基础胰岛素类似物的申请，如果获得批准，将为1型和2型糖尿病患者提供每周一次的选择。

In announcing the review, the FDA has asked for public comment on Awiqli.The announcement comes after Novo revealed in February that the FDA needed an additional three months to review the application, pushing an April target decision date into the third quarter. The company said that the delay was necessary because of changes it made to its application.The company is mum on whether it was surprised that the FDA is calling for the adcomm.

在宣布审查时，FDA要求公众对Awiqli发表评论。此前，Novo在2月份透露，FDA需要额外三个月的时间来审查该申请，将4月份的目标决定日期推到了第三季度。该公司表示，延迟是必要的，因为它对其应用程序进行了更改。该公司对FDA呼吁adcomm是否感到惊讶保持沉默。

Novo also stopped short of revealing what information the regulator is seeking. 'We look forward to participating in these discussions with the committee and are confident in the potential of once-weekly basal insulin icodec to help manage diabetes for people who require insulin,' Novo said.Last month, the Europe Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended Awiqli for approval.

Novo也没有透露监管机构正在寻求什么信息。诺沃说：“我们期待着参加与委员会的这些讨论，并对每周一次的基础胰岛素icodec的潜力充满信心，以帮助需要胰岛素的人管理糖尿病。”。上个月，欧洲药品管理局（Europe Medicines Agency）的人用药品委员会（CHMP）建议Awiqli获得批准。

Novo expects an official approval from the European Commission to come in late May.In an interview with Fierce Pharma three years ago, Novo CEO Lars Fruergaard Jorgensen called the treatment a “revolution” in the field, adding that “the world has never seen a weekly insulin.”RelatedNovo Nordisk closes in on EU approval for its once-weekly insulin AwiqliNovo is seeking approval for Awiqli after conducting six phase 3 studies which included more than 4,000 patients.

诺和诺德预计欧盟委员会将于5月下旬正式批准。三年前，诺和诺德首席执行官Lars Fruergaard Jorgensen在接受Force Pharma的采访时称，这种治疗方法是该领域的一场“革命”，并补充说“世界上从未见过每周一次的胰岛素”。诺和诺德接近欧盟批准其每周一次的胰岛素AwiqliNovo，在进行了六项包括4000多名患者在内的3期研究后，正在寻求Awiqli的批准。