This content material initially appeared on diaTribe. Republished with permission.
By Anna Brooks
Approval for Novo Nordisk’s much-anticipated once-weekly insulin has been denied right now by the U.S. Meals and Drug Administration. The medicine has been authorized in Europe, Canada, Australia, Japan, and China.
There was hope that insulin icodec can be the primary once-weekly insulin authorized within the U.S. That received’t be occurring – at the very least not in 2024 – following a letter from the FDA to the producer.
Icodec developer Novo Nordisk lately shared the disappointing information, citing in a press launch that the approval was denied on account of “requests associated to the manufacturing course of and the sort 1 diabetes indication.”
No additional particulars had been made accessible on what manufacturing roadblocks Novo Nordisk wants to deal with earlier than they’ll search approval once more.
The FDA’s Advisory Committee concluded there wasn’t sufficient proof that the advantages of a weekly insulin outweighed the dangers of hypoglycemia for folks with kind 1 diabetes.
Whereas scientific trials in folks with kind 2 diabetes have discovered that insulin icodec lowers A1C and improves time in vary with out rising the danger of hypoglycemia, neither the Advisory Committee nor the FDA addressed this subject.
As soon as manufacturing points are resolved, it seems seemingly that the FDA will approve insulin icodec for folks with kind 2 diabetes. Insulin icodec has already been authorized below the model title Awiqli in Australia, Canada, the European Union, Switzerland, and Japan for folks with kind 1 and sort 2 diabetes. It’s additionally been authorized in China for folks with kind 2 diabetes.
Novo Nordisk stated it is going to handle the FDA’s requests for added data however famous that this effort received’t be accomplished in 2024.
“We consider within the potential of once-weekly basal insulin icodec for these residing with diabetes who require basal insulin remedy,” stated Dr. Martin Lange, Novo Nordisk’s growth chief, within the press launch. “We’ll work carefully with the FDA to determine the following steps wanted to finish the overview so we will present this novel remedy choice to adults residing with diabetes.”
