FDA On Novo's Diabetes Combo: It's Complicated

A May 24 advisory panel meeting is critical for Novo Nordisk's effort to convince the FDA to approve the Danish company's fixed-dose combination diabetes drug IDegLira – which unites Victoza (liraglutide) with Tresiba (insulin degludec) – but regulators questioned the firm's trial design.

Some concerns raised by the FDA about a fuzzy trial design used by Novo Nordisk AS for a fixed-dose formulation that unites two of its already marketed drugs – Victoza (liraglutide), a glucagon-like peptide 1 (GLP-1) receptor agonist, and Tresiba (insulin degludec), a basal insulin – may throw a wrench into the firm's hope of turning the combo product into what the Danish company is hoping will be a big moneymaker.

The FDA wants its Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to help the agency grapple with various issues with...

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

More from Business

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

 
• By 

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.

Finance Watch: Scorpion Spinout Antares Launches With $177m For Precision Medicines

 
• By 

Private Company Edition: Antares’ lead asset will enter the clinic in 2026 after Lilly committed up to $2.5bn for Scorpion’s Phase I/II PI3Kα inhibitor STX-478. Also, Amplify raised $200m for its first biotech VC fund and Mosanna raised an $80m series A round, among other financings.

UCB Follows Fellow European Pharmas With Major US Investment

 
• By 

The Belgian drugmaker is boosting its biologics capacity over the pond.

AstraZeneca Taps Into China’s R&D Engine With CSPC Alliance

 

After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.

More from Scrip

AstraZeneca Taps Into China’s R&D Engine With CSPC Alliance

 

After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.

Executives On The Move: New CMOs At Instil Bio, Nkarta & Catalyst Pharma

Recent moves in the industry include changes at the top at iOnctura and Orca Bio, plus Sutro Biopharma, Tenpoint Therapeutics and Helix BioPharma get new CFOs.

In Brief: Starton Moves Low-Dose Lenalidomide To Phase IIa For Multiple Myeloma

 

Study to add to safety and tolerability data for infused formulation and may help identify optimal dose for future pivotal trial.