Wegovy wins FDA nod for heart health benefits
08 Mar 2024
Phase 3Drug Approval
US regulators have approved a label expansion for Novo Nordisk's weight-loss drug Wegovy (semaglutide) to reduce the risk of major adverse cardiovascular events (MACE), including heart attacks and strokes. The decision could potentially broaden insurance coverage for the GLP-1 agonistGLP-1 agonist and similar treatments for obesity.
"We are very pleased that Wegovy is now approved in the US as the first therapy to help people manage their weight and reduce CV risks," said Martin Holst Lange, head of development at Novo Nordisk. The once-weekly injection was first cleared for chronic weight management in adults back in 2021, and later expanded to include children as young as 12 years old.
'Major advance' for public health
The latest approval is based on the Phase III SELECT cardiovascular (CV) outcomes trial, which demonstrated that Wegovy significantly reduced the risk of MACE by 20% compared to placebo when added to standard care.
Specifically, the new indication is for reducing risks of MACE including CV death, non-fatal heart attack or non-fatal stroke in overweight or obese adults with established CV disease. The label update also includes data from SELECT showing a risk reduction in CV death by 15% and a risk reduction in death from any cause by 19%, both compared to placebo.
"Providing a treatment option that is proven to lower this CV risk is a major advance for public health," stated John Sharretts, who directs FDA's division of diabetes, lipid disorders and obesity. Novo Nordisk has also asked EU regulators to expand the use of Wegovy for heart conditions, although they have not yet weighed in on the request.
Lifting coverage barrier
Private insurers will evaluate the new indication for Wegovy before making coverage decisions, said a spokesperson for America's Health Insurance Plans, an industry trade group. At the moment, Medicare is currently legally barred from covering drugs for weight-loss alone, although Novo Nordisk has been trying to make the case that its drug is not just about weight and appearance, but about improving aspects of overall health.
Aside from the SELECT trial, the company also recently reported that semaglutide, which is marketed for diabetes as Ozempic, cut the risk of kidney disease progression and death from kidney or CV complications by 24% in certain patients in another Phase III trial.
However, besides the issue of insurance coverage, ongoing supply constraints for Wegovy have also been a persistent barrier to broader uptake, although the company is working to ramp up production.
Competitor battle
The new label could allow the Danish drugmaker to maintain an edge over Eli Lilly, whose rival weight-loss treatment Zepbound (tirzepatide) was approved in the US last November. Despite the dual GIP and GLP-1 agonistGLP-1 agonist's efficacy in helping people lose weight, it has yet to demonstrate a CV impact – and a readout from the study searching for such a benefit was recently delayed. On its fourth quarter earnings call, Eli Lilly bumped back the timing for the Phase III SURPASS CV outcomes study from the end of 2024 into 2025. For a comprehensive timeline of clinical weight loss programmes, see Vital Signs: Key obesity readouts of 2024.
Meanwhile, Novo Nordisk is working on a once-daily oral formulation of semaglutide, and also provided an early glimpse this week of another potential oral weight-loss contender – this time targeting both GLP-1 and amylin. For more, see Spotlight On: Novo Nordisk’s latest obesity outlook - 5 key takeaways.
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