Novo Nordisk’s Semaglutide Achieves ‘Cardiodiabesity’ Label

With Wegovy’s new indication for cardiovascular risk reduction in patients with overweight and obesity, the migration of diabetes drugs from a single disease state to address a host of interrelated conditions reaches a new milestone.

cardiovascular pills
• Source: Shutterstock

The migration of diabetes drugs from a single disease state to address a host of interrelated conditions reached a new milestone with the FDA’s approval of Novo Nordisk A/S’s Wegovy (semaglutide) as the first weight loss drug with an indication for reducing risk of major cardiovascular events in patients with overweight or obesity.

More from US FDA Performance Tracker

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

US FDA’s March Approval Candidates Take Aim At Established Markets

 

March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.

GSK’s Penmenvy, Bavarian Nordic’s Vimkunya Clear US FDA, Will CDC Follow?

 

The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.

Rapidly Rising RMAT Designations Crack CBER’s Communication Freeze

 

The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.

More from Regulatory Trackers

US FDA’s March Approval Candidates Take Aim At Established Markets

 

March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.

EU Decision Time For Topical Gene Therapy Beremagene Geperpavec And Five Others

 

The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.

GSK’s Penmenvy, Bavarian Nordic’s Vimkunya Clear US FDA, Will CDC Follow?

 

The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.