Benzinga - by Piero Cingari, Benzinga Staff Writer.
Novo Nordisk A/S (NYSE:NVO)’s Wegovy garnered the Food and Drug Administration’s approval for expanded use Friday, marking what the drugmaker said is a pivotal turn in the treatment landscape for individuals grappling with the dual challenges of obesity and established cardiovascular disease.
This approval underscores a new era in preventive health strategies, targeting a significant reduction in major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attacks (myocardial infarction) and nonfatal strokes.
Leap Forward In Cardiovascular, Weight Management Therapy
The FDA’s green light is anchored in the evidence from the SELECT cardiovascular outcomes trial. This study puts forth an argument for Wegovy’s efficacy, showcasing a statistically significant 20% reduction in the risk of MACE compared to placebo, all while integrated into the standard care regimen.
“We are very pleased that Wegovy is now approved in the U.S. as the first therapy to help people manage their weight and reduce cardiovascular risks,” Martin Holst Lange, executive vice president and head of development at Novo Nordisk, said in a statement.
Lange added the authorization marks a significant breakthrough for individuals battling obesity and cardiovascular disease, highlighting the potential of Wegovy to extend life expectancy.
Novo Nordisk has widened its ambition into the European Union, where it is seeking a similar label expansion.
Shares of Novo Nordisk were 1.9% lower on Friday, but trimmed some losses after the news release. The Danish pharma giant’s stock has risen by 90% over the last year.
The exchange-traded fund holding the largest allocation of Novo Nordisk’s shares is the VanEck Pharmaceuticals ETF (NYSE:PPH), with the Danish company comprising nearly 9% of its portfolio.
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