Senators demand answers from drugmaker about discontinuation of popular insulin Levemir

Three U.S. Senators say they are "alarmed" Novo Nordisk discontinued U.S. sales of a popular insulin brand and are demanding answers from the pharmaceutical giant they say left patients without an affordable substitute.

In a letter Tuesday to Novo Nordisk's top executives, Sens. Jeanne Shaheen, D-N.H., Raphael Warnock, D-Ga., and Elizabeth Warren, D-Mass., said the company's decision to discontinue Levemir, a long-acting insulin, "failed to take into consideration patient access to affordable, long-acting insulin substitutes."

Last November, Novo Nordisk announced it would stop selling the injectable FlexPen version of Levemir this month and halt sales of Levemir vials by December 2024. The decision to discontinue Levemir was announced just before Novo Nordisk's 65% list price cut of Levemir took effect on January 1.

In the letter addressed to president and CEO Lars Fruergaard Jørgensen, at the company's headquarters in Denmark, and U.S.-based president Douglas J. Langa, the senators said they were "alarmed by Novo Nordisk’s decision to discontinue Levemir before allowing the price reduction to go into effect."

More than 7 million U.S. patients use insulin products. All patients with Type 1 diabetes and some with Type 2 diabetes rely on insulin to survive.

Novo Nordisk representatives did not immediately respond to request for comment about the senators' letter.

Novo Nordisk previously told USA TODAY it would discontinue U.S. sales of Levemir due to global manufacturing constraints and the availability of other forms of insulin. The company also blamed pharmacy managers and insurers who limited access to Levemir on drug formularies, the list of drugs insurers cover for patients.

The senators demanded the company executives describe "issues related to formulary placement" and global supply chain constraints that might have challenged production of the drug. They also asked Novo Nordisk to explain how patients now on Levemir will get access to "similar long-acting insulin products without gaps in coverage and at similar cost-sharing."

Two other, long-acting "basal" insulins on the market include Sanofi's Lantus and Novo Nordisk's Tresiba. When Levemir is no longer available to U.S. consumers, the senators asked whether the company plans to reduce the price of Tresiba.

"We have vigorously advocated for universal access to affordable insulin products," the senators wrote. "Unfortunately, that goal remains out of reach for too many Americans, in particular for in-demand, long-actinginsulins with proven outcomes."

The senators also wanted to know whether other drug manufacturers had contacted Novo Nordisk about making a biosimilar version of the drug. Biosimilar drugs, which must be approved by the Food and Drug Administration, generally are used the same way and have the same strength, dosage and side effects.

The senators asked whether Novo Nordisk would help "facilitate" a biosimilar Levemir if another drug company already has expressed interest. If not, the senators requested that Novo Nordisk "commit to making the relevant patents, technologies and manufacturing capabilities available" to a drug company that expresses interest in the future.

The senators want to ensure patients have access to Levemir, whether it's provided by Novo Nordisk or an approved biosimilar from another drugmaker, according to an aide for Sen. Shaheen.

Long-acting insulins lengthen the time between injections and allow patients to maintain baseline blood glucose levels. Of all the long-acting insulins, Levemir is the only one that is FDA-approved for pregnancy, the senators said.

Parents of several teens told USA TODAY they prefer Levemir to other long-acting insulins because it metabolizes more quickly and allows active teens to adjust their dosages more quickly.

This article originally appeared on USA TODAY: Why is Levemir being discontinued? Senators demand answers