Dive Brief:

潜水简介：

Shortages affecting the availability of Eli Lilly’s top-selling diabetes and weight-loss drugs have now been resolved, the Food and Drug Administration said Wednesday.

美国食品和药物管理局周三表示，影响礼来最畅销的糖尿病和减肥药物供应的短缺问题现已得到解决。

Lilly has assured regulators that product availability and manufacturing capacity is enough to meet both current and projected demand in the U.S., the FDA said. The drugs, sold as Mounjaro and Zepbound, are both made from the active ingredient tirzepatide, which has been on the FDA’s shortage list for almost two years..

FDA表示，礼来已向监管机构保证，产品供应和生产能力足以满足美国当前和预计的需求。这些名为Mounjaro和Zepbound的药物均由活性成分tirzepatide制成，近两年来，该成分一直列在FDA的短缺清单上。。

The FDA’s announcement comes two months after the drugs were marked as “available” in the agency’s database. On Wednesday, the FDA put compounders on notice that the official resolution of the shortage means legal restrictions on making copies of the drugs will be back in place.

美国食品和药物管理局（FDA）在其数据库中将这些药物标记为“可用”后两个月宣布了这一消息。周三，美国食品和药物管理局（FDA）向复方制剂公司发出通知，正式解决短缺问题意味着将恢复对药品复制的法律限制。

Dive Insight:

潜水洞察：

Mounjaro and Zepbound are part of the GLP-1 class of drugs that also includes Novo Nordisk’s Ozempic and Wegovy. The medicines’ powerful effects in fighting obesity, and many other related health problems, have supercharged a market that analysts say could reach $100 billion or more by 2030.

Mounjaro和Zepbound是GLP-1类药物的一部分，其中还包括诺和诺德的Ozempic和Wegovy。这些药物在对抗肥胖和许多其他相关健康问题方面的强大作用，使市场变得更加强大，分析师表示，到2030年，该市场可能达到1000亿美元或更多。

But demand for the new medications has far outstripped supply. Both Lilly and Novo Nordisk have been frantically working to increase production, with Lilly announcing a $5 billion investment in manufacturing capacity for the drugs in May.

但对新药的需求远远超过了供应。礼来和诺和诺德都在疯狂地增加产量，5月份礼来宣布对这些药物的生产能力投资50亿美元。

While the drugs faced shortages, direct-to-consumer operators stepped in, taking advantage of rules that allow compounding pharmacies to make medicines with supply issues. Now that the shortage for Lilly is over, the FDA on Wednesday warned that facilities can’t make compounded drugs that simply copy agency-approved ones..

虽然药品面临短缺，但直接面向消费者的运营商介入，利用允许复配药店生产有供应问题药品的规定。既然礼来的短缺已经结束，FDA周三警告说，工厂不能简单地复制机构批准的药物来生产复合药物。。

However, the law does allow exemptions in certain cases, including for compounded drugs that are personalized for a specific patient. And executives at one of the leading companies that relies on compounding, Hims and Hers, see that exception as a path for continued business.

然而，该法律确实允许在某些情况下豁免，包括针对特定患者个性化的复合药物。Hims和Hers是一家依靠复利的领先公司，他们的高管将这一例外视为继续经营的途径。

“Our personalization dosages that exist on the platform today are offering fantastic high-touch care to patients that otherwise really wouldn’t be able to experience the benefits of GLP-1,” CEO Andrew Dudum told analysts on a conference call in August. “And I would expect in the future, in a post-shortage world, this also continues to exist for patients as an access point.”.

首席执行官安德鲁·杜杜杜姆（AndrewDudum）在8月份的一次电话会议上告诉分析师：“我们目前平台上存在的个性化剂量为那些无法体验GLP-1益处的患者提供了梦幻般的高触感护理。”。“我预计在未来，在短缺后的世界中，这也将继续作为患者的接入点。”。

Hims and Hers currently offer compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. The FDA’s database continues to list semaglutide in shortage.

Hims和Hers目前提供semaglutide的复合版本，semaglutide是Ozempic和Wegovy的活性成分。美国食品和药物管理局（FDA）的数据库继续列出短缺的semaglutide。

The FDA warned consumers that there may still be local interruptions in supply of Mounjaro and Zepbound as manufacturers and distributors move the medicine to pharmacies around the country. Lilly has also warned patients of potentially “choppy” availability as shortages ease.

FDA警告消费者，随着制造商和分销商将药品转移到全国各地的药店，Mounjaro和Zepbound的供应可能仍会受到当地中断。礼来公司还警告患者，随着短缺的缓解，可能会出现“断断续续”的供应。