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Senate To Review Novo Nordisk's Levemir Insulin Discontinuation

Senate To Review Novo Nordisk's Levemir Insulin Discontinuation

參議院將審查諾和諾德的勒衛鳴胰島素停售
Benzinga ·  01:49

Democratic U.S. Senate aides will meet with executives from Novo Nordisk A/S (NYSE:NVO) on Tuesday to discuss the ramifications of the company's decision to cease selling its long-acting insulin Levemir in the U.S. by the end of 2024.

民主黨美國參議院助手將與諾和諾德公司(NYSE:NVO)的高管於週二會面,討論該公司決定在2024年底停止在美國銷售其長效胰島素Levemir的後果。

Senators Jeanne Shaheen, Raphael Warnock, and Elizabeth Warren had previously expressed concerns in an April letter regarding the announcement to discontinue Levemir.

參議員珍妮·沙欣(Jeanne Shaheen)、拉斐爾·瓦諾克(Raphael Warnock)和伊麗莎白·禾倫(Elizabeth Warren)此前曾在4月的一封信中表示關注,對停售Levemir的聲明提出了異議。

Also Read: Novo Nordisk's Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review.

此外還需要注意,諾和諾德公司即將面臨FDA審查,其一週注射一次的胰島素藥物有低血糖風險。

In November last year, Novo Nordisk announced that it would discontinue the long-acting insulin Levemir in the U.S. due to manufacturing constraints, reduced patient access, and the availability of alternative options.

去年11月,諾和諾德公司宣佈將停用Levemir長效胰島素在美國銷售,由於製造約束、患者減少使用,以及替代選項的可用性。

Novo Nordisk maintains that patients have ample time to transition to other options.

諾和諾德公司認爲,患者有充足的時間過渡到其他選擇。

The company's May letter to lawmakers indicated that no known plans for manufacturers to produce a biosimilar version of Levemir exist, and Novo would not assert any patent claims against such versions.

該公司在5月致議員的信中表示,沒有已知的製造商計劃生產Levemir的生物類似物版本,諾和不會對這些版本提出任何專利權主張。

Reuters highlighted that the move has sparked concern among experts who note the stress and inconvenience for diabetes patients required to change their insulin regimens.

路透社強調,此舉引發了專家的擔憂,他們指出,糖尿病患者需要改變胰島素治療方案需要花費精力和不便。

Novo Nordisk, along with Eli Lilly And Co (NYSE:LLY) and Sanofi SA (NASDAQ:SNY), controls 100% of the insulin market in the U.S.

諾和諾德公司,以及禮來公司(Eli Lilly And Co)(NYSE:LLY)和賽諾菲安萬特公司(Sanofi SA)(NASDAQ:SNY)控制了美國胰島素市場的100%。

Recently, these three companies agreed to cut U.S. insulin prices by up to 75% starting in 2024, addressing political pressures to make these essential diabetes treatments more affordable.

最近,這三家公司同意從2024年開始削減美國胰島素價格高達75%,以緩解政治壓力,使這些必不可少的糖尿病治療更加經濟實惠。

This decision comes as Novo Nordisk reports record profits, driven mainly by the commercial success of its weight-loss drugs Wegovy and Ozempic, part of a new class of GLP-1 agonists.

這一決定是在諾和諾德公司報告錄得創紀錄的利潤後做出的,這主要得益於其減肥藥Wegovy和Ozempic的商業成功,這是一類GLP-1激動劑的一部分。

Levemir's U.S. sales amounted to 1.27 billion Danish crowns ($185.6 million) in 2023, while Tresiba, Novo Nordisk's other daily long-acting insulin, generated 1.33 billion crowns.

Levemir在2023年在美國的銷售額爲12.7億丹麥克朗(18560萬美元),而諾和諾德公司的另一種日常長效胰島素Tresiba則創造了13.3億克朗的銷售收入。

Amid increasing scrutiny, Novo Nordisk continues to navigate the challenges posed by its product portfolio and market demands.

在面臨越來越多的審查之際,諾和諾德公司繼續應對其產品組合和市場需求所構成的挑戰。

Last week, the FDA issued a Complete Response Letter regarding Novo Nordisk's Biologics License Application for a once-weekly basal insulin codec for diabetes mellitus.

上週,FDA發佈了一份有關諾和諾德公司生物類似物許可證申請的完整回覆函,其注射性basal insulin codec治療糖尿病。

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提出了與製造過程和1型糖尿病適應症相關的要求,批准申請審查之前必須滿足這些要求。

Price Action: NVO shares are down 0.38% at $140.86 at the last check on Tuesday.

股票價格變動:截至週二最後一次查詢,諾和諾德公司股價下跌0.38%,爲140.86美元。

  • Eli Lilly's Weekly Insulin Dose On Par With Commonly Used Daily Doses, Phase 3 Studies Show.
  • 禮來公司的周胰島素劑量與常用每日劑量相當,第3期研究顯示。

Photo via Shutterstock

圖片來自shutterstock。

譯文內容由第三人軟體翻譯。


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