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 presently by the U.S. Meals and Drug Administration. The treatment has been authorised in Europe, Canada, Australia, Japan, and China.
There was hope that insulin icodec could be the primary once-weekly insulin authorised within the U.S. That gained’t be taking place – at the least not in 2024 – following a letter from the FDA to the producer.
Icodec developer Novo Nordisk not too long ago shared the disappointing information, citing in a press launch that the approval was denied attributable to “requests associated to the manufacturing course of and the sort 1 diabetes indication.”
No additional particulars have been made accessible on what manufacturing roadblocks Novo Nordisk wants to handle earlier than they will 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 medical 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 challenge.
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 authorised underneath the model identify Awiqli in Australia, Canada, the European Union, Switzerland, and Japan for folks with kind 1 and kind 2 diabetes. It’s additionally been authorised in China for folks with kind 2 diabetes.
Novo Nordisk stated it’ll tackle the FDA’s requests for extra data however famous that this effort gained’t be accomplished in 2024.
“We imagine 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 are going to work carefully with the FDA to determine the following steps wanted to finish the evaluate so we will present this novel remedy choice to adults residing with diabetes.”
