Insulin Degludec’s CV Risks Can Be Studied Post-Approval, Cmte. Says

The majority of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee agrees the potential advantages of Novo Nordisk’s long-acting basal insulin justify approval before a cardiovascular risk signal seen in a meta-analysis is fully explored in a dedicated outcomes study.

Novo Nordisk AS’ long-acting basal insulin degludec should be approved despite the presence of a potentially concerning cardiovascular safety signal, an FDA advisory committee said Nov. 8.

The Endocrinologic and Metabolic Drugs Advisory Committee voted 8-4 that efficacy and safety data support marketing of Tresiba (insulin degludec)...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 United States

How Could MFN Pricing Impact Commercial Market?

 
• By 

Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.

COVID-19 mRNA Vaccine Labels Now Quantify Myocarditis Risk, But ACIP Wants Other Changes

 
• By 

New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.

Medicare’s Combo Products Negotiation Plan Conflicts With US FDA Standards, Firms Argue

 
• By 

The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.

US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.

More from North America