FDA Surprises Novo Nordisk by Not Approving Once-Weekly Insulin

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 treatment has been permitted in Europe, Canada, Australia, Japan, and China. 

There was hope that insulin icodec can be the primary once-weekly insulin permitted 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 just lately shared the disappointing information, citing in a press launch that the approval was denied resulting from “requests associated to the manufacturing course of and the kind 1 diabetes indication.”

No additional particulars have 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 growing the chance of hypoglycemia, neither the Advisory Committee nor the FDA addressed this problem.

As soon as manufacturing points are resolved, it seems doubtless that the FDA will approve insulin icodec for folks with kind 2 diabetes. Insulin icodec has already been permitted beneath the model identify Awiqli in Australia, Canada, the European Union, Switzerland, and Japan for folks with kind 1 and sort 2 diabetes. It’s additionally been permitted in China for folks with kind 2 diabetes.

Novo Nordisk stated it is going to deal with the FDA’s requests for added 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 dwelling with diabetes who require basal insulin remedy,” stated Dr. Martin Lange, Novo Nordisk’s growth chief, within the press launch. “We’ll work intently with the FDA to determine the following steps wanted to finish the evaluate so we are able to present this novel remedy choice to adults dwelling with diabetes.”