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.

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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.
  • The group intends to file for a label expansion in a few months, and will probably get it

This almost certainly means that a cardioprotective claim will be granted for Rybelsus’s label, but the commercial significance for the Danish group might not be huge. Many doctors will already be prescribing Rybelsus on the assumption that it will cut CV events

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