Novo Nordisk is pulling its regulatory submissions to expand the use of its obesity drug Wegovy for a common type of heart failure, saying that waiting for more data on cardiovascular outcomes could bolster its case.
Trials of Wegovy in the condition, heart failure with preserved ejection fraction (or HFpEF), have primarily looked at the drug’s effects on symptoms and physical function. The company plans to reapply to expand Wegovy’s label early next year when it has more data on complications such as hospitalizations and cardiovascular-related deaths, Martin Lange, Novo’s head of development, said Wednesday on an earnings call. The company had initially submitted its applications in January to regulators in the U.S. and Europe.
Novo’s move comes after competitor Eli Lilly recently reported topline results of its obesity drug Zepbound in HFpEF. The trial, unlike studies of Wegovy in HFpEF, studied cardiovascular outcomes as a primary endpoint. It found that Zepbound cut the risk of major problems — including heart failure-related urgent visits or hospitalizations, intensification of diuretic treatment, or cardiovascular-related deaths — by 38% compared to placebo.
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