Smooth AdCom Passage Expected For Novo's Semaglutide Despite Retinopathy Queries

Novo Nordisk's Victoza follow-on semaglutide, forecast to become the third once-weekly GLP-1 product available on the highly competitive US diabetes market, is expected to secure a market-leading spot, by revenue, before 2025.

Monorail
Novo's semaglutide is speeding towards US launch before end of 2017 • Source: Shutterstock

Novo Nordisk AS' experimental once-weekly GLP-1 inhibitor semaglutide will face its first US FDA advisory committee on Oct. 18 – the type 2 diabetes treatment is forecast to move easily through the proceedings despite some safety concerns around diabetic retinopathy complications.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee is expected to question Novo about the increased risk in diabetic retinopathy...

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 Alimentary/Metabolic

Eolo Pharma Advances In Obesity With Thermogenesis Approach

 
• By 

Emerging Company Profile: Early-stage biotech Eolo will seek cash and deals for its novel obesity drug SANA after positive Phase I results for weight loss, lean muscle mass preservation and fat mass reduction.

Protagonist Hopes To Come From Behind In Obesity With Oral Triple Agonist

 

The company announced plans to move an oral GLP-1/GIP/GCG receptor agonist peptide into clinical development for obesity in 2026.

Altimmune’s Phase IIb MASH Data Send Share Price Plunging

 
• By 

Altimmune’s stock price did not recover on June 27, after a 57% dip the day before, despite efforts to position pemvidutide as both resolving MASH and offering weight loss.

Veru’s Enobosarm Market Potential Enhanced By New Obesity Data

 
• By 

The late-stage biotech posted results from the maintenance extension portion of its Phase IIb QUALITY trial in which enobosarm reduced weight regain and helped preserve lean mass in patients who discontinued their semaglutide weight-loss treatment.

More from Therapy Areas

Novartis Secures Approval For First Malaria Therapy for Babies

 
• By 

Coartem Baby to be rolled out in eight African countries in the autumn.

Could Apogee Rival Regeneron/Sanofi, Lilly After Phase II Eczema Data Win?

 
• By 

Apogee Therapeutics reports data from Phase II APEX trial of its long-acting antibody against atopic dermatitis, showing similar efficacy to Regeneron/Sanofi’s Dupixent and Eli Lilly’s Ebglyss.

Cogent Peaks With Bezaclastinib SUMMIT Results

 

The biotech announced positive topline results from the Phase II SUMMIT study in non-advanced systemic mastocytosis, with data for advanced SM and GIST expected later this year.