Novo Nordisk and Sanofi diabetes combo drugs receive US recommendation

By Dan Stanton

- Last updated on GMT

Image: iStock/bernie_moto
Image: iStock/bernie_moto

Related tags Novo nordisk Diabetes mellitus Diabetes mellitus type 2

The US FDA has voted in favour of two combination type 2 diabetes drugs putting Novo Nordisk and Sanofi head-to-head in a crowded market.

On Tuesday, a US Food and Drug Administration (FDA) advisory committee voted unanimously in favour of approving IDegLira, Novo Nordisk’s combination of Tresiba (insulin degludec) and Victoza (liraglutide) to treat adults with type 2 diabetes.

And yesterday saw the same committee vote 12-2 in favour of Sanofi’s iGlarLixi, another combination – with Sanofi’s own basal insulin glargine and GLP-1 receptor agonist lixisenatide - which will also offer patients a once-daily, single injection.

Both results were welcomed by the respective drugmakers, with Sanofi’s R&D president Elias Zerhouni saying in a statement that his firm’s fixed-ratio product “may address some of the unmet needs of adults living with type 2 diabetes who are considering initiating or intensifying insulin,”​ through the two ingredients, “both of which can contribute to HbA1c lowering.”

But if both combinations end up approved, Novo Nordisk and Sanofi could end up in a pricing battle to gain market dominance, according to Diabetic Investor’s David Kliff.

“Many in the diabetes world will hail these two votes as major victories, that patients will soon have more treatment options to choose from,” ​he said in a note. But “from a practical standpoint we still believe that both Sanofi and Novo will find it tough going with payors.”

Furthermore, while there is a place for both products on the market, there are many other options available to patients with Type 2 diabetes and so, Kliff believes, neither will become a blockbuster.

“Whatever sales are reached they will come at a step price as payors will do what they always do when there are two me-too copycat drugs which do the same thing the same way competing against each other: they will demand and receive lower prices combined with higher rebates in exchange for favorable formulary placement.”

Novo Nordisk saw its product approved in the EU in September 2014 under the name Xultophy, while Sanofi submitted its drug for regulatory review in March this year.

Related news

Related product

A Guide Through the API Drug Development Pipeline.

A Guide Through the API Drug Development Pipeline.

Content provided by Lonza Small Molecules | 04-Apr-2023 | Insight Guide

With the complexities associated with API and HPAPI drug development, it’s necessary to lean on the experts. With Q&A sections, insights and articles...

Related suppliers

Follow us


View more