Novo Nordisk limited Wegovy starter doses for new US patients in May 2023
People trying to start Wegovy faced a supply squeeze as Novo Nordisk reserved starter doses for existing patients, while the FDA warned compounded semaglutide is not reviewed for safety.
In May 2023, Novo Nordisk began holding back the lowest starter doses of Wegovy from people newly starting treatment in the United States, a step taken so that supply could go to patients already on the drug [1]. Company executives discussed the decision during an earnings call on June 20, 2023 [1].
Wegovy is the brand name for semaglutide, a GLP-1 agonist. The FDA approved it to treat overweight and obesity, while the same molecule is sold as Ozempic and Rybelsus to treat type 2 diabetes [1]. Ozempic and Wegovy have been on the FDA's drug shortage list since 2022 [1]. Novo said on the call that it has been adding production capacity but has not kept up with demand [1].
Which starter doses were affected, how many prescriptions went unfilled, and how long the limits lasted have not been disclosed [1]. The company also has not said how many people moved to compounded semaglutide while supply was tight [1].
On the same June 20, 2023, date as the call, Novo Nordisk announced it had started legal proceedings against certain US medical spas, weight-loss and wellness clinics and compounding pharmacies [1]. The company said it wanted to stop misleading advertising, trademark infringement and unlawful sales of compounded products that claim to contain semaglutide without FDA approval [1]. It said those marketing and sales practices have created a high risk of consumer confusion and deception, along with possible safety concerns [1]. None of the targeted businesses were named, and the company gave no further details about them [1].
Novo told CNN its actions aim to keep marketplace entities from engaging in misleading or false advertising, infringing its trademarks, or illegally distributing compounded products that claim to contain semaglutide, and that it will keep evaluating steps against entities that violate its intellectual property rights [1]. It also launched semaglutide.com, a site offering ways to tell FDA-approved products apart from counterfeit ones [1]. People who have a semaglutide prescription should check that their medicine is an authentic version, the company said [1].
Compounding is the process of combining, mixing or altering ingredients to make a medication suited to an individual patient, and it can include combining two or more drugs, according to the FDA [1]. When a drug is in shortage, compounders may be able to prepare a version of it if they meet certain requirements of the Federal Food, Drug, and Cosmetic Act, the agency said, but it does not review those products for safety, effectiveness or quality [1].
The FDA warned in May 2023 about some compounded semaglutide products. It said it had received reports of adverse events in people who used compounded semaglutide, and that patients should not use a compounded drug when an approved one is available [1]. Some compounders may use salt forms such as semaglutide sodium and semaglutide acetate, which have different active ingredients from those in the approved drugs; the agency said it is not aware of any basis for compounding with those salts and that they have not been shown to be safe and effective [1].
Novo Nordisk expects Wegovy to be taken long term. "Based on the knowledge we have today, we're talking about a chronic treatment in order to maintain weight loss," said Dr. Martin Holst Lange, executive vice president of development [1]. He said the company has shown patients can keep off about 15% of body weight over two years while staying on Wegovy, and that those who stop the drug regain weight [1]. Novo plans to study whether weight loss can be maintained after the medication is stopped [1].
Why it matters for patients
The limit landed on new starts rather than on people already in treatment, so a first prescription could be delayed while refills continued [1]. Compounded semaglutide became an alternative for some patients, but the FDA does not review those products for safety, effectiveness or quality, and the agency says patients should not use a compounded drug when an approved product is available [1]. Salt forms draw particular concern because the agency says they have not been shown to be safe and effective [1], and the FDA has received reports of adverse events tied to compounded semaglutide [1]. The company's view that treatment is chronic also shapes expectations, since the data it cited show weight returning after the drug is stopped [1].
What happens next
Novo says it is building manufacturing capacity, but it has not said when starter doses will reopen to new US patients [1]. No start date or length has been given for the planned study on maintaining weight loss after stopping [1]. The legal proceedings have no announced timeline, and the businesses involved remain unidentified [1].
Sources
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