Source – Novo Nordisk
Novo Nordisk has been capitalizing on the momentum generated by its weight loss drug, Wegovy, which made a splash in the market in 2021, garnering significant attention and even facing occasional supply shortages. However, a pivotal cardiovascular outcomes trial has the potential to significantly alter the landscape for this emerging medicine.
In an expansive Phase III trial, the drug demonstrated a remarkable 20% reduction in the risk of major adverse cardiovascular events when compared to a placebo and standard treatment, as announced by Novo on Tuesday. Specifically, the trial evaluated the efficacy of Wegovy’s 2.4-mg dose in lowering the risk of cardiovascular death, heart attacks, and strokes.
The trial encompassed a participant pool of 17,604 individuals and examined the drug’s effects over a span of up to five years among individuals aged 45 and above who were overweight or obese and had existing cardiovascular conditions. To qualify for the trial, patients had to lack any history of diabetes.
With this trial success, Novo Nordisk anticipates pursuing an expansion of the drug’s label to incorporate the newly acquired cardiovascular risk-reduction data in the United States and Europe within the current year. The company revealed that a comprehensive breakdown of the study’s findings, dubbed SELECT, will be unveiled at an upcoming scientific conference.
Conducted across 41 countries and spanning over 800 sites, the trial commenced in 2018.
“People living with obesity have an increased risk of cardiovascular disease but to date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke or cardiovascular death. Therefore, we are very excited about the results from SELECT showing that semaglutide 2.4 mg reduces the risk of cardiovascular events. SELECT is a landmark trial and has demonstrated that semaglutide 2.4 mg has the potential to change how obesity is regarded and treated.”
– Martin Holst Lange, executive vice president for Development at Novo Nordisk
Adding to the excitement, analysts at Intron Health speculated that Medicare is likely to approve reimbursement for obesity drugs following this outcome. Moreover, they believe that the cardiovascular data might serve as a protective factor for Wegovy against potentially more potent therapies, such as Eli Lilly’s Mounjaro, whose own cardio outcomes study isn’t projected to conclude until 2027.
Related: Saxenda Is Now In Low Supply As Novo Nordisk Issues A Supply Warning Till 2023
Nonetheless, manufacturing challenges are expected to continue affecting the rollout of Wegovy, according to the Intron team. While they anticipate that active pharmaceutical ingredients won’t pose a significant issue, they foresee ongoing limitations in fill-and-finish capacity for Novo.
This could result in drug shortages persisting for the next two to three years, leading to a phased international launch outside of the United States.
Since its introduction in 2021, Wegovy’s demand has been so substantial that Novo has occasionally faced difficulties in maintaining sufficient supply. In early May, the company announced a reduction in the supply of lower dosage strengths in the US to ensure consistent patient care.
