1. Scrip
  2. >>Therapy Areas
  3. >>Alimentary/Metabolic

Xultophy Expands Label In Europe As First US Approval Decision Looms

 
• By Lucie Ellis-Taitt

Novo Nordisk has secured a European label extension for its dual type 2 diabetes therapy Xultophy for use in patients with moderate renal impairment – the EU nod is a another boost of confidence the Danish firm needs as it awaits a US regulatory decision.

The European Commission has approved the use of Novo Nordisk AS' Xultophy, a first-to-market once-daily combination of long-acting basal insulin Tresiba and glucagon-like peptide-1 receptor agonist Victoza in one pen, for use in type 2 diabetes patients with moderate renal impairment.

Xultophy's new drug application for use in type 2 diabetes patients is still pending at the US FDA, with a...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Alimentary/Metabolic

Lilly Looks For Muscle-Sparing Candidates In Pact With Juvena

 
• By Joseph Haas

Deal Snapshot: Including its internal efforts with bimagrumab, Lilly has been seeking a muscle-sparing therapy to complement GLP-1 obesity drugs, such as Zepbound.

Novo Nordisk Teams With Deep Apple On Non-Incretin Obesity Approach

 
• By Joseph Haas

Novo Nordisk will partner with privately held Deep Apple to study a novel, non-incretin target that could be better suited than GLP-1s for long-term obesity treatment.

Metsera’s Amylin Analog Stars In Obesity Phase I

 
• By Joseph Haas

Intended as obesity monotherapy and for combination with the firm’s GLP-1 analog, MET-0233i showed best-in-class efficacy with placebo-like tolerability at low doses.

Regeneron Buys Tirzepatide-Like Product With Eye On Muscle-Preserving Combinations

 
• By Jessica Merrill

Regeneron is bringing in its own GIP/GLP-1 agonist, establishing a path to develop proprietary obesity drug combinations with its internal muscle-sparing drugs.

More from Therapy Areas

Who Dares Wins? Roche Moves Parkinson’s Candidate Into Phase III Despite Near Miss

 
• By Andrew McConaghie

Open-label extension data have persuaded Roche to move prasinezumab into Phase III, where it believes a few tweaks to the study design could turn a near miss into success.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: breaking down big pharma’s executive pay; US vaccine panel upheaval; Merck’s RSV approval; MFN and Japan; and the future of Pfizer and Arvinas’s partnership.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.