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诺沃压力GLP-1复合剂因FDA禁令生效

Novo pressures GLP-1 compounders as FDA ban takes hold

BioPharma Dive 等信源发布 2025-05-22 23:13

可切换为仅中文


Novo Nordisk is ramping up its war on compounders making versions of its top-selling semaglutide medicine as the regulatory grace period for their products officially ends.

诺和诺德正在加大对生产其最畅销药物司美格鲁肽的复合制剂商的打击力度,因为这些产品的监管宽限期已正式结束。

The Danish drugmaker on Thursday said it’s

丹麦制药商周四表示

launching a “Choose the Real Thing” campaign

发起“选择真实之物”活动

designed to alert consumers of the potential dangers of knockoff products. It’s also offering self-paying customers a $300 discount for their first prescription of name-brand Wegovy and intensifying legal actions that have already spawned almost 120 lawsuits.

旨在提醒消费者假冒产品可能带来的危险。该公司还为自费顾客提供首次处方品牌Wegovy 300美元的折扣,并加强法律行动,目前已引发近120起诉讼。

“Mass compounding of `semaglutide’ is illegal, dangerous and must stop now,” Dave Moore, Novo’s executive vice president of U.S. operations, said in the company’s statement.

“大规模配制司美格鲁肽是非法的、危险的,必须立即停止,”诺和诺德美国业务执行副总裁戴夫·摩尔在公司声明中表示。

Novo’s profits soared over the last few years as consumers raced to take drugs made with semaglutide – including Ozempic for diabetes and Wegovy for obesity – along with similar medicines made by Eli Lilly. Both Novo and Lilly struggled to keep up with demand, and compounders and telehealth companies like Hims & Hers stepped in, offering cheaper compounded versions of the GLP-1 medications..

诺和诺德的利润在过去几年里飙升,因为消费者争相购买用司美格鲁肽制成的药物——包括用于糖尿病的奥兹匹克和用于肥胖症的威戈维——以及礼来公司生产的类似药物。诺和诺德和礼来都难以满足需求,复合药剂师和远程医疗公司如Hims & Hers介入,提供更便宜的GLP-1复合版本药物。

The Food and Drug Administration allowed the compounded products while shortages persisted. But now that Novo and Lilly have caught up with demand, the FDA said that

食品和药物管理局在短缺持续期间允许使用这些复合产品。但是现在诺和与礼来已经赶上需求,FDA表示

large-scale compounding must stop

大规模复合必须停止

. The agency allowed compounding pharmacies to phase out their work, and the last grace period ended Thursday.

.该机构允许复合药房逐步停止他们的工作,最后的宽限期在周四结束。

But Novo clearly sees a continued risk of compounding, which has

但是,诺和公司显然认为,复合风险仍在继续,这

hurt earnings growth

损害收益增长

and added to woes including supply chain issues, clinical trial setbacks and increased competition from Lilly. Novo this month announced its

并增加了包括供应链问题、临床试验挫折以及来自礼来公司加剧的竞争在内的困境。诺和本月宣布了其

longtime CEO, Lars Fruergaard Jørgensen, would step down

长期担任首席执行官的拉尔斯·弗鲁尔加德·约根森将卸任。

.

An

一个

attempt

尝试

by compounders to reverse the FDA decision in court

通过复合者在法庭上推翻FDA的决定

failed last month

上个月失败了

, but companies are still seeking ways around the ruling. At least one, Noom, plans to keep offering versions of semaglutide, saying its tailored method of titrating dosages complies with the law allowing compounding to fit personalized patient needs,

,但公司仍在寻求绕过裁决的方法。至少有一家公司,Noom,计划继续提供司美格鲁肽的版本,称其调整剂量的定制方法符合允许根据个性化患者需求进行配制的法律。

Axios reported

Axios 报道称

.

Novo contends that almost all of the compounded semaglutide is manufactured in China and by other foreign suppliers and may be dangerous for patients. The company notes that the FDA hasn’t subjected compounders to the same rigorous production standards that Novo and Lilly must meet.

诺和诺德表示,几乎所有复方的司美格鲁肽都在中国和其他外国供应商处生产,可能对患者有危险。该公司指出,FDA并未要求复方制剂生产商遵循诺和诺德和礼来必须达到的同样严格的生产标准。

The one-time Wegovy discount offer is good through June 30. It allows patients with a prescription for semaglutide who are new to brand-name Wegovy to pay $199 for their first month of medicine. After that, the cost will climb to $499 a month.

一次性Wegovy折扣优惠持续到6月30日。该优惠允许持有司美鲁肽处方且初次使用品牌Wegovy的患者首月支付199美元购买药物。之后,费用将上涨至每月499美元。