Late last year, Novo Nordisk responded to a growing shortage of popular Ozempic with a plan to cut down on production of its older diabetes med Victoza to make room for more Ozempic. Still, the shortages continued to persist and are now expected to last into this year’s fourth quarter, according to a letter from Novo and the European Medicines Agency (EMA).
The combination of increased demand and capacity constraints at some manufacturing sites has resulted in supply issues and even “out-of-stock situations” for Ozempic, the agency said in the letter (PDF) directed at healthcare professionals distributed “in agreement” with Novo.
These factors have triggered intermittent shortages for all strengths of the popular diabetes medicine, and the situation is expected to extend into the fourth quarter of the year, according to the letter.
Healthcare providers were urged to continue to limit putting new patients on Ozempic until supply improves. As for Victoza, shortages continue in some European countries while others have experienced greater supply since this year’s first quarter. Still, “no new patients should be started on Victoza” to allow those already on the treatment to continue receiving their doses, the EMA said.
If neither drug is available for patients currently using the meds, patients should be switched to another injectable GLP-1 product, according to the letter.
Not all EU member states will be impacted by the supply shortages, according to the letter. Novo continues to expand its global supply capacity, and its production facilities are operating around the clock, a spokesperson noted over email.
When the company opted to reduce Victoza production last November, which it disclosed through a similar letter with the EMA, Ozempic shortages were expected to lighten up by 2024’s first quarter. At the time, Novo said it would limit the supply of lower dose strengths or starter doses to help curb the initiation of new patients.
Meanwhile in the U.S., Ozempic is currently marked as available on the FDA’s shortage list, as are all doses of the drug’s weight-loss counterpart Wegovy save for the lower 0.25 mg strength. Still, the U.S. has seen shortages as well, prompting a surge of counterfeit and compounded versions of Ozempic. Novo has cracked down on those sellers with trademark infringement lawsuits and settled with two Florida sellers in February.
Novo's GLP-1 rival Eli Lilly has faced similar shortage issues and subsequent counterfeiters of its obesity med Zepbound, which the company recently made available directly to patients at a steep discount.
Novo and Lilly have both been busy scaling up production for their respective injectables, with Novo most recently pledging $4.1 billion to build a second fill-finish plant at its Clayton, North Carolina, campus.
Novo Holdings' $16.5 billion buyout of CDMO Catalent should also help on the capacity front. Through the deal, Novo Nordisk is slated to pick up three fill-finish sites for $11 billion.