On Monday, Novo Nordisk (CSE:NOVOb) (NOVOB:DC) (NYSE: NYSE:NVO) received a new share price target of DKK1,054.00, up from the previous DKK925.00, while retaining an Outperform rating from TD (TSX:TD) Cowen. This adjustment follows the recent FDA approval of an expanded label for the pharmaceutical company's drug Wegovy.
The label now includes the drug's capability to reduce cardiovascular (CV) risk in individuals with both obesity and cardiovascular disease (CVD), as demonstrated in the SELECT trial.
Last week, Novo Nordisk announced the FDA's endorsement of Wegovy's label expansion. This decision was based on the results of the SELECT cardiovascular outcomes trial, which showed a 20% reduction in major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal heart attacks, or non-fatal strokes. The trial included adults with overweight or obesity issues who also had established CVD.
The SELECT study's findings indicated that the reduction in MACE risk was consistent across various subgroups, including different ages, sexes, races, ethnicities, body mass indices, and levels of renal function impairment.
Moreover, the updated label incorporates data revealing a 15% decrease in cardiovascular death risk and a 19% reduction in the risk of death from any cause, both in comparison to a placebo.
The expanded label for Wegovy also includes further clinical data from the SELECT trial. The drug's new indication is expected to provide a competitive edge against Zepbound, another treatment in the same category. Novo Nordisk is also seeking similar label expansion in the European Union, with a decision anticipated in 2024.
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