Novo limits Wegovy starter doses for new US patients

Novo Nordisk limited the lower starting doses of Wegovy available to new US patients in May 2023 because it could not make enough of the obesity drug to meet demand. The company said the restriction was meant to keep people who had already started treatment from being cut off mid-course.

The company confirmed the move publicly on an earnings call on June 20, 2023, saying it had been ramping up production capacity for Wegovy after struggling to keep up with demand, and that it had limited doses for new patients in the US the previous month so it could meet the needs of people already taking the medicine ^[1].

Wegovy is the obesity-treatment brand of semaglutide. The same molecule is sold as Ozempic and Rybelsus for type 2 diabetes ^[1]. Both Ozempic and Wegovy had been on the US Food and Drug Administration's drug shortage list since 2022 ^[1].

The compounding spillover

The supply squeeze had a direct side effect: it opened the door wider to compounded semaglutide. Under the Federal Food, Drug, and Cosmetic Act, when a drug is in shortage, compounders may be able to prepare a version of it if they meet certain requirements, the FDA said. But the agency does not review those compounded products for safety, effectiveness or quality ^[1].

In May 2023, the FDA warned about some compounded versions of semaglutide, saying it had received reports of adverse events in people who used them and that patients "should not use a compounded drug if an approved drug is available" ^[1]. The agency also flagged that some compounders appeared to be using salt forms — semaglutide sodium and semaglutide acetate — which have different active ingredients from the approved drugs. "The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements. … Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective," the FDA said ^[1].

Novo Nordisk followed with legal action. On June 20, 2023, the company said it had begun proceedings against some US medical spas, weight loss or wellness clinics and compounding pharmacies "to cease and desist from false advertising, trademark infringement and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide" ^[1]. It said those practices "have created a high risk of consumer confusion and deception as well as potential safety concerns," but did not name the companies involved ^[1]. Novo also launched a website, semaglutide.com, with information on telling FDA-approved products from what it called counterfeit ones ^[1].

Why it matters for patients

The practical effect of a starter-dose limit falls on people at the very beginning of treatment. Semaglutide is normally started low and stepped up over time, so restricting the small doses effectively slows or pauses new starts while leaving established patients supplied ^[1]. That created a two-tier situation: people already in the system kept going, while newcomers faced pharmacy hunts, waiting, or offers of compounded alternatives that the FDA has not reviewed for safety, effectiveness or quality ^[1].

The interruption question matters more because of how the drug works over time. Novo's development chief, Dr. Martin Holst Lange, said in a June 2023 briefing: "Based on the knowledge we have today, we're talking about a chronic treatment in order to maintain weight loss" ^[1]. He noted that patients staying on Wegovy maintained weight loss of about 15% over two years, while those who stopped regained weight ^[1]. The company said it planned to study whether people could maintain weight loss after stopping, but expected chronic therapy for the foreseeable future ^[1].

What happens next

Novo did not say publicly how long the starter-dose limit would last, which specific dose strengths were affected, or how many US patients were involved — none of that is spelled out in the available sources. The company said only that it was expanding production capacity ^[1]. Whether supply recovered enough to lift the restriction, and when, is not addressed in these sources.