This content originally appeared on diaTribe. Republished with permission.
By Anna Brooks
Approval for Novo Nordisk’s much-anticipated once-weekly insulin has been denied at this time by the U.S. Food and Drug Administration. The medication has been approved in Europe, Canada, Australia, Japan, and China.
There was hope that insulin icodec would be the first once-weekly insulin approved in the U.S. That won’t be happening – at least not in 2024 – following a letter from the FDA to the manufacturer.
Icodec developer Novo Nordisk recently shared the disappointing news, citing in a press release that the approval was denied due to “requests related to the manufacturing process and the type 1 diabetes indication.”
No further details were made available on what manufacturing roadblocks Novo Nordisk needs to address before they can seek approval again.
The FDA’s Advisory Committee concluded there wasn’t enough evidence that the benefits of a weekly insulin outweighed the risks of hypoglycemia for people with type 1 diabetes.
While clinical trials in people with type 2 diabetes have found that insulin icodec lowers A1C and improves time in range without increasing the risk of hypoglycemia, neither the Advisory Committee nor the FDA addressed this issue.
Once manufacturing issues are resolved, it appears likely that the FDA will approve insulin icodec for people with type 2 diabetes. Insulin icodec has already been approved under the brand name Awiqli in Australia, Canada, the European Union, Switzerland, and Japan for people with type 1 and type 2 diabetes. It’s also been approved in China for people with type 2 diabetes.
Novo Nordisk said it will address the FDA’s requests for additional information but noted that this effort won’t be completed in 2024.
“We believe in the potential of once-weekly basal insulin icodec for those living with diabetes who require basal insulin therapy,” said Dr. Martin Lange, Novo Nordisk’s development chief, in the press release. “We will work closely with the FDA to identify the next steps needed to complete the review so we can provide this novel treatment option to adults living with diabetes.”
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