Novo Nordisk A/S NVO released the headline results from the SELECT cardiovascular outcomes trial, better than the 15-17% expected by investors and analysts.
The trial compared subcutaneous once-weekly semaglutide 2.4 mg with placebo as an adjunct to the standard of care to prevent major adverse cardiovascular events (MACEs) for up to five years.
The trial enrolled 17,604 adults aged 45 years or older with overweight or obesity and established cardiovascular disease with no prior history of diabetes.
The trial achieved its primary objective by demonstrating a statistically significant and superior reduction in MACE of 20% for people treated with semaglutide 2.4 mg compared to placebo.
The study's primary endpoint was defined as the composite outcome of the first occurrence of MACE, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
All three primary endpoint components contributed to the superior MACE reduction demonstrated by semaglutide 2.4 mg. 1,270 first MACEs were accrued.
In the trial, semaglutide 2.4 mg appeared to have a safe and well-tolerated profile in line with previous semaglutide 2.4 mg trials.
Novo Nordisk expects to file for regulatory approvals of a label indication expansion for semaglutide 2.4 mg (Wegovy) in the U.S. and the EU in 2023.
The landmark trial data shows Wegovy has "the potential to change how obesity is regarded and treated," said Martin Holst Lange, executive vice president for development at Novo Nordisk.
Price Action: NVO shares are up 15.90% at $187.04 during the premarket session on the last check Tuesday.
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