FDA rejects Novo Nordisk’s weekly basal insulin

Novo Nordisk’s bid to provide a once-weekly basal insulin product for people with diabetes, reducing the number of injections needed, has hit a major hurdle in the US.

The FDA sent the Danish drugmaker a complete response letter (CRL) declining to approve the drug, insulin icodec, saying that it needs more information on its manufacturing process, as well as more data on how well it performs in people with type 1 diabetes.

In a statement, Novo Nordisk said it was looking into the requirements of the CRL and “does not expect to be able to fulfil the requests during 2024,” delaying the programme for several months at least.

It’s a setback for the company, which has been vying to become the first company to bring a once-weekly basal insulin product to the US market, but comes after insulin icodec has already been approved in the EU, Canada, Australia, Japan, and Switzerland under the Awiqli brand name, as well as in China.

Eli Lilly is its nearest rival, developing a once-weekly rival, known as insulin efsitora, which has shown safety and efficacy in two of five ongoing phase 3 trials.

Insulin icodec is an insulin analogue that binds strongly to albumin in the blood and reduces its affinity for insulin receptors, effectively creating a reservoir of insulin that gradually releases over time. It would allow patients with insulin-dependent diabetes to cover their basal insulin needs with one injection per week, as opposed to once or twice daily.

Basal insulin helps regulate blood glucose levels throughout the day, while on-demand or ‘bolus’ insulin is used to manage the blood glucose rise that follows meals.

The rejection by the FDA has not come as a complete surprise, given that an advisory committee voted by seven to four in May against the use of the drug in type 1 diabetics, due to concerns about its potential to cause low blood sugar (hypoglycaemia).

There had been speculation that the FDA may approve insulin icodec for use in type 2 diabetes only, which is a much larger market than type 1, but the manufacturing issues seem to have scuppered that idea.

Awiqli has been cleared for both types of diabetes in all its current markets except China, where it can be used for type 2 only.

“We believe in the potential of once-weekly basal insulin icodec for those living with diabetes who require basal insulin therapy,” said Martin Lange, head of development at Novo Nordisk.

“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.”