European regulators are poised to approve Novo Nordisk’s blockbuster drug Wegovy to reduce the risk of cardiovascular events in patients who are overweight or obese.
The EU’s Committee for Medicinal Products for Human Use (CHMP) recommended that Wegovy’s label be expanded, more than four months after the FDA approved the cardio-focused addition. The new regulatory nod Thursday is based on data showing that Wegovy reduced the risk of major cardiovascular events by 20% compared to placebo when added onto standard of care. Such events include cardiovascular death, non-fatal heart attack or non-fatal stroke.
With CHMP’s blessing, Novo expects the European Medicines Agency to update the label within a month. The company says that while the exact mechanism of action resulting in reduced cardiac risks is unknown, it’s “likely multifactorial.”
Beyond the sales implications, Wegovy’s foray into cardiovascular protection is symbolic in a move beyond just weight loss, where the drug has made its mark.
Martin Holst Lange“The SELECT data demonstrated that in addition to helping people manage their weight, Wegovy has the potential to protect lives by reducing the risks of major adverse cardiovascular events,” Novo’s head of development Martin Holst Lange said in a statement.
Lilly is similarly testing its weight loss and obesity treatment tirzepatide to prevent cardiovascular events, though an ongoing Phase 3 trial is in patients with type 2 diabetes. That’s slated to complete a year from now. Lilly also recently launched a cardiovascular events trial for lepodisiran, focused on patients with elevated lipoprotein(a) levels.