Senate To Review Novo Nordisk's Levemir Insulin Discontinuation

Democratic U.S. Senate aides will meet with executives from Novo Nordisk A/S NVO on Tuesday to discuss the ramifications of the company’s decision to cease selling its long-acting insulin Levemir in the U.S. by the end of 2024.

Senators Jeanne Shaheen, Raphael Warnock, and Elizabeth Warren had previously expressed concerns in an April letter regarding the announcement to discontinue Levemir.

Also Read: Novo Nordisk’s Once-Weekly Insulin Flagged With Risk Of Low Blood Sugar Ahead Of FDA Review.

In November last year, Novo Nordisk announced that it would discontinue the long-acting insulin Levemir in the U.S. due to manufacturing constraints, reduced patient access, and the availability of alternative options. 

Novo Nordisk maintains that patients have ample time to transition to other options.

The company’s May letter to lawmakers indicated that no known plans for manufacturers to produce a biosimilar version of Levemir exist, and Novo would not assert any patent claims against such versions.

Reuters highlighted that the move has sparked concern among experts who note the stress and inconvenience for diabetes patients required to change their insulin regimens.

Novo Nordisk, along with Eli Lilly And Co LLY and Sanofi SA SNY, controls 100% of the insulin market in the U.S.

Recently, these three companies agreed to cut U.S. insulin prices by up to 75% starting in 2024, addressing political pressures to make these essential diabetes treatments more affordable.

This decision comes as Novo Nordisk reports record profits, driven mainly by the commercial success of its weight-loss drugs Wegovy and Ozempic, part of a new class of GLP-1 agonists.

Levemir’s U.S. sales amounted to 1.27 billion Danish crowns ($185.6 million) in 2023, while Tresiba, Novo Nordisk’s other daily long-acting insulin, generated 1.33 billion crowns.

Amid increasing scrutiny, Novo Nordisk continues to navigate the challenges posed by its product portfolio and market demands.

Last week, the FDA issued a Complete Response Letter regarding Novo Nordisk’s Biologics License Application for a once-weekly basal insulin codec for diabetes mellitus.

In the letter, the FDA has requests related to the manufacturing process and the type 1 diabetes indication before the application review can be completed.

Price Action: NVO shares are down 0.38% at $140.86 at the last check on Tuesday.

Read Next:

• Eli Lilly’s Weekly Insulin Dose On Par With Commonly Used Daily Doses, Phase 3 Studies Show.

Photo via Shutterstock