Dive Brief:
- The Food and Drug Administration rejected Novo Nordisk’s application to sell a once-weekly insulin treatment called icodec, sending the Danish drugmaker a series of requests related to manufacturing and its potential use in Type 1 diabetes.
- Regulators have indicated they can’t complete their review until the requests are resolved, Novo Nordisk said Wednesday. The company said it doesn’t expect to be able to respond to all the issues this year.
- Novo’s description of the FDA’s Complete Response Letter did not outline any concerns about safety or efficacy. However, a panel of outside advisers to the FDA in May concluded that the benefits of the treatment did not outweigh its risks in Type 1 diabetics.
Dive Insight:
Novo is one of the world’s premier manufacturers, along with Indianapolis-based Eli Lilly. Both have been working for years to offer patients a more convenient option than the once-daily injections of insulin that many diabetics require.
Lilly in May announced positive Phase 3 results for its once-weekly insulin, called efsitora alfa. Novo has already won approval in the European Union, Canada, Australia, Japan and Switzerland to sell icodec under the brand name Awiqli for both Type 1 and Type 2 diabetes. The medicine is also approved in China for Type 2 diabetes.
But an FDA advisory panel in May expressed concerns about the potential for icodec to trigger a higher risk of hypoglycemia that would require more patient monitoring in type 1 diabetics. The committee didn’t discuss the use of the drug in type 2 diabetes.
Novo said Wednesday that it’s committed to bringing icodec to the U.S. market and will work closely with the FDA to fulfill its requests. Novo isn’t alone in facing a stumbling block over manufacturing; a number of recent rejections from the agency have centered on the issue.
Novo and Lilly are both trying to launch a new option as they and other makers of insulin face increasing scrutiny on pricing. Last year, both companies moved to sharply cut the price of several branded insulin products.
Though they have long dominated the diabetes market, Novo and Lilly most recently have benefited from the incredible success of their drugs used to treat obesity. Demand has been so high they are spending billions on manufacturing to meet it. They’re also competing with an ever-growing number of companies vying to develop potential challengers.