Novo Nordisk’s once-weekly insulin has been turned down by the FDA, and the Danish pharma likely won’t be refiling until next year.
The FDA rejection comes after the EU, Canada, Australia, Japan and Switzerland approved insulin icodec, under the brand name Awiqli, for both type 1 and type 2 diabetes. In China, it’s approved only for type 2 diabetes.
The US regulator is requesting more information relating to the manufacturing process and the type 1 diabetes indication, according to Novo Nordisk. The drugmaker added that it “does not expect to be able to (fulfill) the requests during 2024.”
In May, the agency convened an advisory committee to discuss insulin idodec and flagged concerns about increased rates of hypoglycemia among patients who took the once-weekly treatment, compared to those who took daily insulin. The experts on the adcomm echoed those concerns, voting 7-4 that the benefits did not outweigh the risks of low blood sugar.
Even the European Medicines Agency, which gave its thumbs-up for the drug, noted elevated rates of hypoglycemic events among patients with type 1 diabetes. As such, it wrote insulin icodec “will mainly be used in patients with type 2 diabetes and should only be used in patients with type 1 diabetes for which a clear benefit of a once-weekly administration is expected.”
Novo Nordisk is one of the three largest insulin makers around the world and recently boasted growing its market share to slightly more than a third. It had pitched the once-weekly insulin as a more convenient alternative to daily options.
Its regulatory journey in the US has been particularly long. Novo Nordisk first filed a BLA in April 2023, but the FDA extended its review by three months.
On top of the monotherapy route, Novo is also testing a combination of insulin icodec with its top-selling GLP-1 semaglutide as a once-weekly candidate for inadequately controlled type 2 diabetes.