Patients resist Novo Nordisk plan to stop making Levemir

A patient advocacy group has started a campaign to stop Novo Nordisk from following through on a plan to stop making insulin product Levemir, arguing that it could leave some diabetics without an effective treatment.

The Alliance to Protect Insulin Choice (APIC) says that alternative basal insulins – used to provide a background dose of insulin – are not always suitable for some patients, including children, teens, pregnant women, and athletes.

Levemir (insulin detemir) has a shorter duration of action than other long-acting basal insulins like Sanofi's Lantus (insulin glargine) and biosimilars and Novo Nordisk's newer product Tresiba (insulin degludec), but is more suitable for people with fluctuating basal insulin needs, claims the group.

That shorter half-life makes it easier to adjust dosages to meet insulin needs, it maintains, while insulin glargine and insulin degludec have side effects that mean some patients are unable to take them.

Novo Nordisk has been selling Levemir in the US for nearly 20 years, and in March 2023 – under pressure from US lawmakers scrutinising the cost of insulin products in the US marketplace – agreed to reduce the price of the product by 65%, effective the start of 2024.

The following November, however, the company said it would discontinue Levemir insulin by the end of 2024, and to expect supply disruptions from the middle of January, according to APIC.

APIC is lobbying Novo Nordisk to continue production of Levemir until a biosimilar is widely available and asking the drugmaker to work with biosimilar manufacturers to make this happen as soon as possible. The organisation has so far managed to obtain around 4,400 signatures in a petition urging Novo Nordisk to continue supplying Levemir worldwide.

Lawmakers in the US have taken notice of the ACIP's concerns. US Senators Elizabeth Warren (D-Mass), Jeanne Shaheen (D-NH), and Reverend Raphael Warnock (D-Ga) have sent a letter (PDF) to Novo Nordisk to request more information on the decision to discontinue production "before allowing the price reduction to go into effect."

"Long-acting insulins are the most prescribed and commonly used insulin, accounting for nearly two-thirds of all insulin treatment visits," the senators wrote. "Of the long-acting insulins, Levemir has the shortest duration and is the only insulin FDA-approved for pregnancy."

They also took issue with Novo Nordisk's claim that its decision to discontinue Levemir was tied to manufacturing constraints, pointing out that the company had recently announced the purchase of three manufacturing facilities from contract development and manufacturing organisation Catalent for $11 billion.

That move – designed to ramp up production of the company’s fast-growing GLP-1 agonist drugs Ozempic for diabetes and Wegovy for obesity – suggests "the company may be prioritising profits over patient care," said the senators.

Patients have told Reuters that they have started stockpiling Levemir and using expired vials as they hope for a successful outcome from APIC's campaign, while a spokesperson for the company reiterated its stance that manufacturing issues – as well as reduced insurance coverage in the US – were behind its decision.

Sales of Levemir were around $565 million last year – with the US accounting for $184 million of that total – having peaked at around $2.5 billion in 2016 when Tresiba was launched onto the market. Tresiba made just over $1.1 billion last year, including $189 million from the US.