Topline
More doses of Novo Nordisk’s popular weight loss drug Wegovy are back in stock in the U.S. after years of shortages and just days after all doses of Eli Lilly’s rival injection Zepbound became available, according to an update on the Food and Drug Administration’s website, though shortages are set to continue as pharma struggles to ramp up production..
Key Facts
The 0.5 milligram (mg) and 1 milligram doses of Wegovy injections are listed as available on the FDA’s drug shortage database following an update on Tuesday.
The drug, known generically as semaglutide and sold as Ozempic to treat diabetes, has featured on the regulator’s shortages list for more than two years due to high demand and Novo Nordisk said it restricted access to lower doses used to start treatment to ensure people already using the injections can continue to access the medicine.
Only the smallest Wegovy dose, a 0.25 milligram injector, remains listed as “limited availability” on the FDA database after an update in late April listed the second-highest dose—a 1.7 milligram injection—become the second listed as available following the largest 2.4 milligram dose, a 2.4 milligram injector pen.
The agency said it is not clear how long the shortage for the smaller dose will last and Novo Nordisk has not indicated when the shortages may end, though it is working to ramp up production.
Last week, an update to the FDA database listed Eli Lilly’s tirzepatide, the generic drug inside the company’s branded weight loss and diabetes therapies Zepbound and Mounjaro, as “available” in all doses after being added to the shortages list in April.
Despite the update, the FDA has not removed tirzepatide or semaglutide injectors from its shortages list and it’s unclear when, or if, and under what conditions it would do so.
What’s Driving The Shortage Of Glp-1 Weight Loss And Diabetes Drugs Like Ozempic?
Novo’s semaglutide and Lilly’s tirzepatide are at the forefront of a promising and growing class of drugs called GLP-1 agonists, which can help control hunger and blood sugar by mimicking the action of gut hormones. While GLP-1s have become famous for their ability to shed weight in a manner that was previously unattainable without surgery, they were initially deployed to treat diabetes. The booming popularity of the drugs, combined with the inability of Novo and Lilly to keep up with demand, has sparked concerns over the ability of people with diabetes to access the medicine keeping their blood sugar levels in check. Off-label use of the diabetes GLP-1 formulations, Ozempic and Mounjaro, for weight loss is reportedly common, though figures are hard to monitor. Even before the drugs were approved and sold specifically for weight loss, there were regular reports of people struggling to access the drugs and research shows the number of new patients being prescribed GLP-1s for diabetes has shrunk over time as prescriptions for weight loss soar. These concerns are likely to grow as pharma firms push into new markets without addressing shortages in existing ones like the U.S.
Tangent
Novo has already secured permission to expand Wegovy’s label to include it as a treatment for cardiovascular conditions and Lilly is actively pursuing Mounjaro and Zepbound for sleep apnea in what could become the first pharmaceutical treatment for the underlying condition. Other indications are also being explored and GLP-1s have shown promise at preventing or treating a wide array of conditions including an array of cancers, Parkinson’s and dementia, liver disease, kidney disease and addiction.
What Doses Of Ozempic, Wegovy, Mounjaro And Zepbound Are Available?
All doses of Mounjaro are listed as available on the FDA shortages list, including:
- 2.5 milligram injection
- 5 milligram injection
- 7.5 milligram injection
- 10 milligram injection
- 15 milligram injection
All doses of Zepbound are listed as available:
- 2.5 milligram injection
- 5 milligram injection
- 7.5 milligram injection
- 10 milligram injection
- 12.5 milligram injection
- 15 milligram injection
All doses of Ozempic are listed as available:
- 0.68 milligram injection
- 1.34 milligram injection
- 2.68 milligram injection
Four out of five Wegovy doses are listed as available:
- 0.5 milligram injection
- 1 milligram injection
- 1.7 milligram injection
- 2.4 milligram injection
One Wegovy dose is listed as “limited availability”
- 0.25 milligram injection
Further Reading
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