Pharmaceutical giants Novo Nordisk and Eli Lilly are in fierce competition to dominate the weight management drug market as their respective obesity medications have taken center stage this summer.
Novo Nordisk's crowning achievements — weight management drug Wegovy and Type II diabetes medication Ozempic — have had a couple of setbacks in recent months, including production shortages and adverse patient complications. Yet, the Danish company continues to grow its market share and acquire other smaller competitors.
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Eli Lilly, maker of Type II diabetes medication Mounjaro, has also experienced strong financial growth this quarter. The company is also anticipating approval from the Food and Drug Administration to use Mounjaro as a weight loss medication, putting the company at even greater odds with Novo Nordisk.
Here is everything you need to know about the changing weight management landscape.
How do these drugs work?
Ozempic and Wegovy are both made with the active ingredient semaglutide. Semaglutide functions as a GLP-1 agonist, which mimics the natural hormone that promotes insulin development in the body to lower blood sugar levels.
Ozempic was approved by the FDA in 2017 as a once-weekly injection medication for insulin-dependent Type II diabetes. Although it is popularly prescribed as a weight loss drug, it does not have FDA approval for that purpose. Wegovy, which is a higher dose of semaglutide than Ozempic, received FDA approval as a weight loss medication in 2021.
The FDA approved Mounjaro, also an injectable medication, in May 2022. The drug treats diabetes differently than Ozempic by activating two different hormone receptors to spur natural insulin production. Although weight loss is also a side effect of Mounjaro, it has not yet received FDA clearance to be prescribed solely for weight management.
How effective are these drugs as weight loss agents?
Aside from the popular buzz from TikTok influencers and media personalities, scientific evidence shows that these products are indeed effective.
One independent analysis found that patients taking GLP-1 agonists contributed to overweight or obese patients losing over 5% of their body weight. Of patients' studies, 50% of participants on semaglutide GLP-1 agonists lost over 5% of their body weight, making it the most effective of the products tested.
According to the FDA, however, diabetic patients taking the maximum dose of 15 milligrams of Mounjaro lost an average of 15 pounds when taken without insulin and 23 pounds when taken with insulin. This was approximately 12 pounds more on average than the weight lost on semaglutide alone. Eli Lilly has stated previously that Mounjaro has been found to reduce body weight in diabetic patients by 16%, or more than 34 pounds, in 17 months.
Patients who do not stay on the medication, however, are likely to lose their progress by gaining the weight back.
Jens Juul Holst, a Danish endocrinologist who helped develop semaglutide, explained that patients are unlikely to stay on the drug because of its appetite-suppressant properties and its corresponding effects on their mood. Host said in an interview with Wired that he does not anticipate patients being willing to stay on the medication for the entirety of their lives.
How does this affect obesity medicine?
New research published in June's issue of Nature Medicine found that obesity changes brain chemistry and the process of nutrient sensing. Compared to those with a healthy-range body mass index, or BMI, obese study participants did not experience the same levels of brain activity or hormone releases or a feeling of fullness after eating.
"For years, we've been telling people that obesity is a disease ... that has fundamental biological processes that are dysfunctional," Angela Fitch of the Obesity Medicine Association previously told the Washington Examiner.
Fitch and other obesity medicine specialists and advocates have long called for treating obesity as a disease in itself and were encouraged by these findings.
This week, Novo Nordisk released data showing that not only does Wegovy improve patient weight loss, but it also reduces heart attacks and strokes by 20%.
The blind study, conducted by SELECT, examined over 17,000 patients since 2018 from 41 countries worldwide, showing a reduction in cardiovascular deaths as well as non-fatal heart events.
The Obesity Medicine Association told the Washington Examiner that they were encouraged by this news, which they argue shows that "treating obesity may not only improve patients' weight but, more importantly, treating obesity in a comprehensive manner may improve the health of patients."
What are the possible complications?
Earlier this month, Louisiana woman Jaclyn Bjorklund, 44, filed a lawsuit against both Novo Nordisk and Eli Lilly for gastrointestinal problems caused by both companies' respective GLP-1 agonists products for Type II diabetes.
The lawsuit alleges that Ozempic and Mounjaro cause both gastroparesis, or delayed stomach emptying, and gastroenteritis, or inflammation of the stomach lining. Both of these conditions resulted in several hospital stays and emergency room visits, Bjorklund claimed.
GLP-1 agonists are also under investigation in both the U.K. and European Union for their connection to suicidal and self-harm thoughts in three instances in Iceland. Mental health consequences are not listed as a side effect on Novo Nordisk's semaglutide products.
A Novo Nordisk spokesperson previously told the Washington Examiner that it is taking the investigations very seriously and that patient health and safety is its top priority.
How has high demand affected Novo Nordisk and Eli Lilly?
A second-quarter earnings report released Thursday revealed that Novo Nordisk expects 2023 sales to be 3% higher than anticipated in May thanks to growing demand for Wegovy and Ozempic. The second-quarter profits for the company topped $3.5 billion, with share prices rising by 18% in a single day after the release of the SELECT trial data.
Novo Nordisk has still had difficulties with manufacturing to increase the supply of semaglutide and injection pens. To mitigate this high demand, the company has limited the availability of starter doses for both Wegovy and Ozempic to ensure that patients already on semaglutide can receive their full treatments.
Even still, Novo Nordisk is doing well enough to have made a $1.1 billion purchase of a smaller pharmaceutical company that focuses only on metabolic disorder drugs, Inversago. Iversago's primary experimental drug has shown promise in stage 3 clinical trials for its weight loss effects.
Eli Lilly's profits from Mounjaro also swelled this summer, earning the company $980 million in the second quarter, nearly $250 million over what was projected. The company's overall profits also skyrocketed 85% to more than $1.76 billion.
Although Eli Lilly, based in Indianapolis, is also experiencing supply chain challenges in production, the company is building a new manufacturing plant in Concord, North Carolina. This is in addition to other renovations to its existing facility in the Tar Heel State.
How will this affect the healthcare industry?
Obesity medicine advocates have continued to push for Wegovy to be covered as a standard benefit by health insurance companies, and the SELECT data may be enough to convince insurers that Wegovy as a preventive treatment is worth the cost.
Lawmakers last month in both the House and Senate introduced bipartisan legislation to cover obesity therapy treatments and medication, including Wegovy, under Medicare.
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“With obesity rates on the rise in our country, we must do more to combat this epidemic head-on," said co-sponsor Sen. Tom Carper (D-DE) at the introduction of the bill. "Too many of those in need are being denied care because of the high cost of medications or inaccessible treatment options."
Novo Nordisk hired a lobbying firm in May to advocate its prime drug to be covered under Medicare for weight loss and obesity management.