The Rise of Weight Management Drug Wegovy
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Pharmaceutical giant Novo Nordisk’s weight loss drug Wegovy was approved in 2021 by the U.S. Food and Drug Administration (FDA) for weight management in overweight and obese adults, and its popularity has since skyrocketed. Despite bottlenecks and supply chain issues constricting the drug’s availability since its rollout, Wegovy has been a commercial success, with Novo Nordisk revising its sales growth expectations from 13–19% up to 24–30%.
Technology Networks spoke with Novo Nordisk’s Clinical, Medical and Regulatory Affairs team to learn more about this drug, the landscape of weight management drugs and its future plans in this space.
Q: Why are pharmaceutical interventions such as Wegovy being developed for overweight/obesity?
A: Obesity is becoming one of the most important global health concerns, with more than 650 million adults living with obesity worldwide. In the UK, upwards of three in five adults are overweight or living with obesity (63%).
Obesity is a complex disease that requires long-term management; it is influenced by a number of different factors including physiological, psychological, environmental, socio-economic and genetic factors. It is also a risk factor for several other chronic diseases such as type 2 diabetes, cardiovascular disease and cancer.
However, current pharmacotherapy treatment options for weight management are limited, and we believe there is a need for additional effective treatment options that can help people living with obesity. By playing a role in helping address these conditions and provide support to those who need it, we can improve the lives of people in the UK as well as help alleviate pressure on the healthcare system.
Q: Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist, with the same active ingredient, semaglutide, as the type 2 diabetes drug Ozempic. How effective is Wegovy for weight management, and how does it achieve this? What is the underlying mechanism?
A: While Ozempic® (semaglutide 1 mg) and Wegovy® (semaglutide 2.4 mg) both contain semaglutide as their active ingredient, Ozempic is indicated for type 2 diabetes and Wegovy is indicated for overweight and obesity.
Semaglutide was originally studied in type 2 diabetes patients and acts in the same way as GLP-1, a hormone produced in the gut, by increasing the amount of insulin that the pancreas releases in response to food. This helps with the control of blood glucose levels. Wegovy was later developed for obesity due to its found weight loss properties.
A two-year trial was conducted to investigate the long-term use of Wegovy. Across the STEP program, people with obesity treated with semaglutide 2.4 mg achieved greater reduction in body weight compared with placebo, with an average weight loss of 15% sustained over 68 weeks.
Q: How does Wegovy differ compared to other weight-management drugs, or other similar GLP-1 receptor agonists?
A: We cannot comment on individual patient treatment options, and it is not our policy to speculate on the efficacy of non-Novo Nordisk products or services.
Saxenda® (liraglutide 3 mg) and Wegovy (semaglutide 2.4 mg) are different molecules, which are both Novo Nordisk GLP-1 receptor agonists. Saxenda is taken as a once-daily injection, while Wegovy is a once-weekly injection.
In the STEP 8 trial comparing Saxenda and Wegovy, participants using Wegovy lost 16% of their baseline bodyweight compared to 6% in those taking Saxenda, when combined with diet and exercise. Wegovy was also seen to have a comparable safety profile.
Q: Wegovy is currently approved by the FDA to be administered as a subcutaneous injection, though previous trials have shown that the oral form is also effective for weight loss. Do you have any plans for trials comparing oral vs subcutaneous Wegovy? Do you think oral forms could help with patient adherence?
A: There are currently no plans for a clinical trial to compare subcutaneous and oral semaglutide for obesity. As part of our commitment to ensure people with obesity receive quality, individualized care, we aim to expand our portfolio to include an oral GLP-1 for weight management (oral semaglutide for obesity). The investigation of oral semaglutide for obesity in weight management aims to provide an alternative therapeutic option for those who prefer oral administration. We cannot comment on trial results until they are published later this year.
Q: Semaglutide was associated with an increased risk of developing thyroid cancer in rodent studies, and pancreatitis has also been observed in humans treated with the drug. Could you tell us more about these findings?
A: Non-lethal thyroid C-cell tumors observed in rodents are a class effect for GLP-1 receptor agonists. The relevance for humans is considered to be low but cannot be completely excluded.
There are long-term surveillance studies examining medullary thyroid cancer for all currently approved long-acting GLP-1 receptor agonist medicines, designed to assess any relevance based on findings in mice and rats.
To date, safety data from randomized controlled trials, long-term cardiovascular outcomes trials, meta-analyses and real-world evidence evaluating the efficacy and safety of GLP-1 receptor agonists have not shown a causal relationship between the use of GLP-1 receptor agonists and the risk of thyroid tumors in people.
We continuously collect and analyze data on the use of our medicines post-marketing authorization and follow international pharmacovigilance standards to report and analyze any adverse events experienced by people taking our medicines.
We work closely with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to ensure that healthcare professionals have a thorough and full understanding of the safety profile of our medicines.
Q: What does the future hold for this area of the pharma space? Are next-generation drugs in the pipeline?
A: We have an ambitious pipeline and are committed to supporting people living with overweight and obesity. Several other molecules are under development, more information will be shared as and when able.
Novo Nordisk’s Clinical, Medical and Regulatory Affairs team was speaking to Dr. Sarah Whelan, Science Writer for Technology Networks.