Novo Bares Its SOUL To Uncertain Effect

A mild benefit in the CV outcomes trial of Rybelsus means a likely label expansion in diabetes patients, but probably not vastly increased sales.

cardiovascular diseases
• Source: Shutterstock

Novo Nordisk’s semaglutide has proven its cardioprotective effect in its incarnations as Ozempic and Wegovy, so it is perhaps not too surprising to see it hit in its other form, Rybelsus. Data from the SOUL cardiovascular outcomes study showed that the oral diabetes medicine cut the rate of major adverse CV events by 14% over placebo.

Key Takeaways
  • Topline data from the SOUL cardiovascular outcomes study showed that Novo Nordisk’s Rybelsus cut the rate of major adverse CV events by 14% over placebo.

This almost certainly means that a cardioprotective claim will be granted for Rybelsus’s label, but the commercial significance for the...

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 Clinical Trials

Another Day Another Win For Novartis’s Ianalumab – This Time In ITP

 
• By 

The Swiss drugmaker’s BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate has chalked up another win in late-stage development, further strengthening its pipeline-in-a-product bid.

Pfizer/Astellas’s Padcev Scores First Big Win In Bladder Cancer Study

 

The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.

IO Biotech Plans Cylembio Filing Despite ‘Narrowly Missed’ Phase III Endpoint

 
• By 

The company plans to meet with the US FDA prior to submitting a BLA before the end of 2025 for its cancer vaccine as a first-line advanced melanoma treatment in combination with Keytruda.

Sjögren’s Success For Ianalumab Shores Up Novartis’s Pipeline-In-A-Product Plans

 

Novartis has strengthened its argument that ianalumab, its BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate, has PIP potential with successful topline results in two Phase III Sjögren’s syndrome trials, after recently dropping the product in hidradenitis suppurativa.

More from Cardiovascular

AstraZeneca’s Amyloidosis Drug Fails In Phase III But Subgroup Hopes Persist

 

Anselamimab was expected to complement Alexion's portfolio of amyloid therapies, but regulators will have to be convinced of its benefits to a patient subgroup in the CARES trial.

Bayer’s Kerendia Gains Blockbuster Indication For Heart Failure

 
• By 

New US approval in heart failure with preserved or mildly reduced ejection fraction should add to Kerendia’s earning power on top of chronic kidney disease indication.

Phase III Success For AstraZeneca’s $5bn Hypertension Hope Baxdrostat

 

Rivals Mineralys could be first to file but AstraZeneca is banking on its cardiovascular market know-how to lead the emerging class.