FDA Rejects Novo Nordisk's Weekly Insulin, Requests Information Related To Manufacturing Process, Type 1 Diabetes
FDA Rejects Novo Nordisk's Weekly Insulin, Requests Information Related To Manufacturing Process, Type 1 Diabetes
On Wednesday, the FDA issued a Complete Response Letter (CRL) related to Novo Nordisk A/S's (NYSE:NVO) Biologics License Application for once-weekly basal insulin icodec for diabetes mellitus.
週三，美國食品藥品監督管理局（FDA）發佈了一封有關Novo Nordisk A/S（紐交所：NVO）生物製品許可申請的完整回覆信（CRL），用於糖尿病的一週一次的基礎胰島素icodec。
In the letter, the FDA has requests related to the manufacturing process and the type 1 diabetes indication before the application review can be completed.
信中，FDA提出了有關製造過程和1型糖尿病適應證的要求，必須在完成申請審查之前履行這些要求。
Related: Novo Nordisk's Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review.
相關新聞：在FDA評審之前，Novo Nordisk的一週一次胰島素面臨低血糖風險的問題。
Novo Nordisk is evaluating the content of the CRL and will work closely with the FDA to fulfill the requests.
Novo Nordisk正在評估CRL的內容，並將與FDA密切合作以滿足要求。
Novo Nordisk does not expect to be able to fulfill the requests during 2024.
Novo Nordisk不指望在2024年之內能夠滿足要求。
'We believe in the potential of once-weekly basal insulin icodec for those living with diabetes who require basal insulin therapy," said Martin Lange, executive vice president for Development at Novo Nordisk.
Martin Lange是諾和諾德開發執行副總裁，他表示：“我們相信一週一次的基礎胰島素icodec對於需要基礎胰島素治療的糖尿病患者具有潛力。”
Novo Nordisk submitted the application for insulin icodec to the FDA in April 2023.
Novo Nordisk於2023年4月向FDA提交了icodec胰島素申請。
In May 2024, an FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting was convened with a panel of independent scientific experts to discuss the benefit-risk of once-weekly basal insulin icodec in type 1 diabetes.
2024年5月，FDA內分泌和代謝藥物諮詢委員會會議召開了一次獨立科學專家小組，討論了一週一次基礎胰島素icodec在1型糖尿病中的獲益與風險。
The panel determined that the available data was insufficient to conclude a positive benefit-risk in type 1 diabetes. The Advisory Committee did not discuss using once-weekly insulin icodec in type 2 diabetes.
小組認爲，現有的數據不足以得出1型糖尿病中積極的獲益與風險結論。諮詢委員會沒有討論在2型糖尿病中使用一週一次的icodec胰島素。
Insulin icodec is approved under the brand Awiqli in the EU, Canada, Australia, Japan, and Switzerland for type 1 and type 2 diabetes and in China for type 2 diabetes.
在歐盟、加拿大、澳洲、日本和瑞士，icodec胰島素以Awiqli品牌獲得批准，適用於1型和2型糖尿病，在中國則適用於2型糖尿病。
Price Action: NVO shares are down 1.46% at $140.65 at the last check on Thursday.
截至週四最後一次查詢，NVO的股票價格下跌1.46%，爲每股140.65美元。
- Only 25% Patients Stick With Novo Nordisk's Wegovy Or Ozempic After 2 Years, A Study Shows; Company Calls Data Insufficient.
- 據一項研究表明，只有25%的患者在使用完諾和諾德的Wegovy或Ozempic兩年後繼續使用，該公司稱數據不足。
Photo via Shutterstock
圖片來自shutterstock。
譯文內容由第三人軟體翻譯。