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Novo Pulls Wegovy Heart Failure Application, Will Resubmit To Get ‘Hard Endpoints’ In Label

 
• By Jessica Merrill and Kevin Grogan

However, Lilly already has outcomes data for tirzepatide, meaning Novo could lose the race to market with a heart failure claim even after being first to the US FDA.

The FDA had some disappointing news for Novo Nordisk. • Source: Shutterstock

Novo Nordisk A/S’s decision to pull its heart failure applications for Wegovy (semaglutide) illustrates that blockbuster drugs can still face challenges with labeling subtleties.

Key Takeaways

  • Novo expects to resubmit semaglutide for a heart failure claim early next year, calling the delay in the hopes of a better label “a really good bargain.”

Incretins, and Wegovy in particular with its obesity and cardiovascular outcomes claims, have been seen as products whose sales are...

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AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach

 
• By Vibha Sharma

Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.

EMA Tackles Guidance Void As Proposals For External Controls Grow

 
• By Neena Brizmohun

The European Medicines Agency is working on defining when and how external controls can be accepted in clinical research. Among other things, it is looking at the planning, design, conduct, analysis and reporting of studies for which external controls are used.

New CTIS Feature To Bridge ‘Communication Gap’ Between Trial Sponsors & EU Assessors

 
• By Vibha Sharma

A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.

Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

 
• By Eliza Slawther

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.

More from R&D

New CTIS Feature To Bridge ‘Communication Gap’ Between Trial Sponsors & EU Assessors

 
• By Vibha Sharma

A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.

Australia Targets Clinical Trial Reform, AI Use And Drug Shortages In 12-Month Plan

 
• By Eliza Slawther

Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.

EU’s Life Sciences Strategy Faces Race Against Time, Says Clinical Trials Community

 
• By Vibha Sharma

The report gave examples of missed opportunities for innovation and patient access, as well as regulatory and operational problems that undermine the conduct of timely clinical trials in Europe.