Dive Brief:

摘要：

Novo Nordisk asked the Food and Drug Administration to approve a pill version of its popular weight loss drug in obesity earlier this year, a spokesperson confirmed to BioPharma Dive.

今年早些时候，诺和诺德公司向食品药品监督管理局申请批准其广受欢迎的减肥药物的口服版本用于治疗肥胖症，该公司发言人向《生物制药潜水》证实了这一消息。

Novo

新星

first reported in 2023

首次报道于2023年

that the drug, an oral form of semaglutide, succeeded in a Phase 3 trial, helping people on the highest dose lose about 15% of their body weight after 64 weeks. However, the Danish drugmaker didn’t seek approval immediately afterwards, instead focusing attention on other medicines that might improve upon the injectable drug it sells as Wegovy for obesity and Ozempic for diabetes. .

这种药物是口服司美鲁肽，在一项三期试验中取得成功，帮助使用最高剂量的人在64周后减掉了大约15%的体重。然而，这家丹麦制药商并未立即寻求批准，而是将注意力集中在其他可能改进其作为Wegovy（用于肥胖症）和Ozempic（用于糖尿病）销售的注射药物的药物上。

The approval filing comes as a race with rival Eli Lilly to develop a weight loss pill has intensified. Lilly last week said its oral GLP-1 pill

审批文件的提交正值与竞争对手礼来公司加紧开发减肥药之际。礼来公司上周表示其口服GLP-1药物

succeeded in a large trial in diabetes

在大型糖尿病试验中取得成功

. That drug, orforglipron, could be submitted to regulators if an ongoing study in obesity also meets its objectives.

如果正在进行的肥胖研究也达到其目标，那么这种药物（orforglipron）可能会提交给监管机构。

Dive Insight:

潜水洞察：

Drugmakers are scrambling to grab a share of a market that could top $100 billion annually next decade, and pills that can spur meaningful weight loss are a big part of those plans.

制药商正在争先恐后地抢占一个市场，这个市场在下一个十年可能每年会突破1000亿美元，而能够促进显著减重的药丸是这些计划的重要组成部分。

Novo has long appeared to be well ahead of others in that race. It had already developed Rybelsus, an oral formulation of semaglutide, for diabetes, and began testing a higher-dose version of it in obesity. And in May 2023, it reported success in a study that tested as high as a 50 milligram oral dose of semaglutide. .

诺和诺德在这一竞赛中似乎早已遥遥领先。该公司已经开发了用于糖尿病治疗的口服司美格鲁肽制剂Rybelsus，并开始测试其更高剂量的版本用于肥胖症治疗。2023年5月，该公司报告了一项研究的成功，该研究测试了高达50毫克的口服司美格鲁肽剂量。

In a statement at the time, the company said it intended to

当时，该公司在一份声明中表示，它打算

seek approval

寻求批准

in the U.S. and Europe in 2023. Yet in an

2023年在美国和欧洲。然而在一个

earnings report

财报

shortly afterwards, Novo conceded that a launch was “contingent on portfolio prioritizations and manufacturing capacity.” The company has several would-be obesity drugs in clinical development, including a closely watched combination therapy called CagriSema. And unlike Lilly’s orforglipron, oral semaglutide is a peptide drug, making its production more complicated than a traditional small molecule. .

不久之后，诺和诺德承认，上市“取决于产品组合的优先级和生产产能”。该公司有几款潜在的减肥药物正在临床开发中，其中包括备受关注的联合疗法CagriSema。此外，与礼来的orforglipron不同，口服司美格鲁肽是一种肽类药物，其生产比传统的小微分子药物更复杂。

However, CagriSema’s progress has been slowed by

然而，CagriSema 的进展因

disappointing study results

令人失望的研究结果

that have forced

迫使

Novo to redraw its development plan

诺沃将重新制定其发展计划

. Another

。另一个

oral prospect

口头展望

has also underwhelmed.

也表现平平。

Through a

通过一个

series of investments

一系列投资

, Novo has finally begun to make enough of Wegovy to meet demand, easing a supply

，诺和终于开始生产足够的Wegovy以满足需求，缓解了供应问题

shortage that’s lasted for years

持续了多年的短缺

. Yet the 25 milligram daily dose involved in the oral version — around 70 times the top dose of

。然而，口服版本涉及的每日25毫克剂量——大约是最高剂量的70倍

Wegovy

伟哥ovy

— could once again test its production capacity.

——可能再次测试其生产能力。

Novo’s executive team will provide more details about the approval application alongside the company’s first quarter earnings report on May 7, the spokesperson said.

诺和的执行团队将于5月7日公布公司第一季度财报时，提供有关批准申请的更多细节，发言人表示。