The limited impact of Ozempic on the U.S. obesity epidemic
The term ‘obesity’ elicits a range of interpretations. Some view it as merely another way to describe excess weight, while others perceive it as a derogatory label for larger body sizes. Still, some consider it a reflection of personal failings, such as a lack of discipline or willpower. However, for over a decade, the medical field has acknowledged obesity as a chronic health condition, akin to diseases like cancer, diabetes, and hypertension. This disease significantly elevates the risk of severe COVID-19 outcomes, is connected to numerous health complications, and is responsible for approximately 4 million preventable deaths annually. Moreover, obesity manifests in various forms, with diverse origins, clinical signs, and treatment responses.
The surge in popularity of GLP-1 medications such as Ozempic, Wegovy, and Mounjaro has somewhat simplified this complex issue. These drugs are often hailed as the ultimate solution to obesity, a perspective that overlooks the multifaceted nature of the condition. Unfortunately, Ozempic alone cannot address America’s obesity crisis. Obesity extends beyond mere physical inactivity or excessive eating. It’s influenced by a range of factors including genetic predispositions, mental health, socio-economic conditions, and environmental factors.
In clinical settings, the variation in obesity cases is significant. For instance, a mutation in the MC4R gene is associated with an 18% increased likelihood of obesity, while certain antipsychotic medications can lead to substantial weight gain. Although GLP-1 medications can be beneficial, they primarily address hormonal imbalances and do not tackle other contributing factors. This reductionist approach is also evident in the use of Body Mass Index (BMI) to diagnose obesity. BMI, initially designed for white European males, often inaccurately represents obesity levels in different ethnic groups, leading the American Medical Association to advise against its sole use. Currently, a global commission of experts is redefining obesity, moving away from height and weight measurements to focus on specific symptoms and signs.
The response to treatment among patients with obesity also varies greatly. For example, the GLP-1 drug Wegovy showed an average body weight reduction of 16% in a study, yet individual results ranged widely. This underscores the need for personalised treatment plans rather than a singular drug-based approach. However, the U.S. healthcare system faces significant challenges in this regard. With only a small number of physicians specialised in obesity treatment and federal restrictions on covering obesity medications, only a fraction of those who could benefit from such treatments receive them. Instead, many are advised to simply eat less and exercise more, a strategy that overlooks the complexity of obesity.
Effective obesity treatment involves a multidisciplinary approach, combining diet, exercise, behavioural therapy, medication, and sometimes surgery. Unfortunately, the scarcity of specialised physicians and the prevalence of misleading diet products and scams exacerbate the issue. The U.S. weight loss market, valued at $160 billion in 2023, is a testament to this. Moreover, misconceptions about GLP-1 medications, such as the idea that they are a cure-all for obesity, lead to unrealistic expectations and criticisms. Like insulin or hypertension treatments, discontinuing GLP-1 drugs can result in a reversal of their effects, a fact that should be recognised rather than criticised.
Addressing obesity, which costs the U.S. around $1.7 trillion annually, requires acknowledging the progress made with GLP-1 drugs while also understanding their limitations. A holistic, patient-centred, and empathetic approach to obesity treatment is essential. This approach should not only address the unique needs and circumstances of each individual but also aim to improve overall health and well-being. While medications like Ozempic, Wegovy, and Mounjaro offer significant potential, they are not the all-encompassing solution often portrayed in the media. A broader, more nuanced understanding and response to obesity is crucial for effective management and treatment.
Read MoreAstraZeneca makes big push into obesity treatment with new pill partnership
AstraZeneca, the United Kingdom’s pharmaceutical giant, has entered a strategic partnership with Eccogene, a Shanghai-based biotech firm, to co-develop a groundbreaking pill designed to combat obesity and type 2 diabetes.
This alliance marks AstraZeneca’s significant foray into the burgeoning sector of weight management medications, underpinned by an exclusive licensing contract focusing on an investigational drug, ECC5004. The said compound is touted to address not only obesity but also a spectrum of cardiometabolic disorders, including heart disease and stroke, ailments afflicting over a billion people worldwide.
Eccogene is poised to receive payments that could sum up to a substantial $2 billion, which is approximately £1.6 billion, as per the agreed terms.
ECC5004 is currently undergoing phase 1 trials, with AstraZeneca setting its sights on advancing to phase 2 clinical evaluations by the subsequent year’s end. Additionally, the pharma titan is nurturing two other nascent-stage injectable obesity therapies.
The innovative ECC5004, if it passes clinical muster, is envisioned to be administered orally once daily, a standalone treatment or potentially in conjunction with other drugs targeting various cardiometabolic diseases. This positions it distinctively against the prevailing injectables that are typically administered weekly.
Operating as a GLP-1 agonist, ECC5004 is designed to replicate the function of the GLP-1 hormone, which is naturally secreted post-food intake.
Pascal Soriot, AstraZeneca’s CEO, highlighted the critical demand for effective obesity interventions across Western nations, Latin America, and South Asia, where abdominal obesity is rampant, precipitating heightened risks of hypertension and diabetes.
Soriot indicated that while the journey to market might span several years, ECC5004 could potentially be more economically accessible than existing options. Due to its simplified chemical structure that permits cheaper production costs, the drug could cater to a wider demographic, including those in lower-income nations where AstraZeneca maintains a robust footprint.
As the competition intensifies in the international market for obesity drugs, demand has surged for Novo Nordisk’s Wegovy and Ozempic, prompting supply challenges. With Wegovy’s pricing set at £73.25 per pack monthly on the NHS and reaching £199 at retail pharmacies, its sales and profits have climbed sharply, elevating Novo Nordisk to be Europe’s highest-valued company by market capitalisation.
Notably, Eli Lilly’s Mounjaro has demonstrated superior weight loss outcomes compared to Wegovy and recently secured approvals for weight management in the UK and US. Market analysts from UBS have predicted that Mounjaro could emerge as one of the most successful pharmaceuticals ever, with projected peak sales around £20 billion.
Pharmaceutical titans Novo Nordisk, Eli Lilly, and Pfizer are all in the race to create oral anti-obesity medications, which promise cost-effectiveness and ease of administration over injections.
Bolstered by its oncology drugs and the diabetes treatment Forxiga, AstraZeneca has reported a 5% revenue increase, totaling $33.8 billion in the year’s first three quarters. The firm also lifted its revenue and profit forecasts for the full year, announcing approvals for additional cancer treatments.
AstraZeneca’s COVID-19 vaccine, crafted in collaboration with Oxford University, was pivotal during the pandemic, credited with saving over 6 million lives globally within its inaugural year as per independent assessments.
However, AstraZeneca currently faces two high court cases in London related to the vaccine’s side effects. The company is expected to contest these allegations.
The World Health Organization last year affirmed the vaccine’s safety and efficacy for individuals 18 years and older, labelling TTS occurrences as exceptionally rare and characteristically presenting severe blood clots.
Read MorePfizer aims to enter the obesity treatment arena with danuglipron, a novel GLP-1 targeting pill
In the competitive landscape of obesity pharmacotherapy, Pfizer is on the cusp of revealing pivotal trial data for its investigational drug danuglipron. This oral medication, administered twice daily, is poised to challenge the market dominance of prominent weight-loss therapies Wegovy and Mounjaro.
Danuglipron operates by influencing the glucagon-like peptide-1 (GLP-1) receptor, which has recently revolutionised the pharmaceutical industry, resulting in substantial economic shifts within the stock market. Through its strategic targeting of this receptor, the drug aims to become a cornerstone in the management of obesity.
Pfizer’s commitment to this endeavour is evident through the initiation of a rigorous Phase 2 trial, designed to thoroughly evaluate danuglipron’s ability to achieve significant weight reduction in individuals with obesity. The financial community, particularly Leerink Partners’ analyst David Risinger, anticipates a full disclosure of the study outcomes potentially by October 31.
For Pfizer, the urgency to diversify its product portfolio has never been greater. The pharmaceutical giant has faced a downturn in its COVID-19 vaccine and therapeutic product demand, compelling a downward revision of its revenue projections. This decline has led to a notable 40% dip in Pfizer’s stock value since the beginning of the year.
The strategic importance of danuglipron has been amplified following Pfizer’s decision in June to discontinue another candidate within its GLP-1 based weight-loss pipeline. The discontinuation was a setback, sharpening the focus on danuglipron as a critical asset in the company’s quest to secure a competitive position in the burgeoning GLP-1 market segment.
As Pfizer prepares to release its findings, the pharmaceutical, obesity care, and weight management industries are watching closely. Danuglipron not only carries the potential to alter the obesity treatment paradigm but also represents a vital opportunity for Pfizer to demonstrate resilience and innovation in the face of shifting healthcare needs. The success of this drug is particularly crucial as Pfizer measures itself against Eli Lilly’s promising GLP-1 oral therapy, which is also vying for a share of this lucrative market.
Read MoreWeight-loss medication Wegovy to be prescribed by NHS amid limited availability
In the UK, the NHS (National Health Service) in England is gearing up to administer the weight-loss drug Wegovy, also known by its scientific name semaglutide, under a “controlled and limited launch.” This initiative, starting from September 4, 2023, will operate via specialist NHS weight management services, where the drug will be prescribed in conjunction with a regimen involving a reduced-calorie diet and physical exercise. The patients targeted in this program must have a Body Mass Index (BMI) exceeding 30 and at least one weight-related health issue to qualify.
The drug, produced by Danish pharmaceutical company Novo Nordisk, received approval for NHS usage earlier in 2023, a sanction granted by the National Institute for Care and Excellence (NICE), which has recommended its usage be capped at a two-year period.
Addressing the prospects of this new treatment, UK Prime Minister Rishi Sunak heralded the introduction of Wegovy as a potential “game-changer” in the battle against obesity, a condition known to predispose individuals to serious health complications such as hypertension, diabetes, and various forms of cancer. The prime minister expressed optimism that this strategy would alleviate the strain on NHS resources, contribute to the reduction of waiting lists, and foster improved health and longevity among the populace.
Echoing these sentiments, Novo Nordisk anticipates that the drug will enhance the range of options available for individuals grappling with obesity, thus facilitating their journey towards achieving healthier body weights.
Earlier in June, the government had set aside £40 million for a pilot project intended to widen the accessibility of weight-loss injections as part of a robust strategy to curb obesity.
However, the initiative encountered a significant hurdle as Novo Nordisk reported an impending shortage in the supply of semaglutide, a situation anticipated to persist for an unspecified period. Despite this, the company reassured that a “proportion of available supply” would be designated for NHS services, with a firm commitment to prioritising patients demonstrating the “highest unmet medical need.”
An official communication from the NHS noted that in line with the guidance from NICE, measures are underway to inaugurate weight management undertakings, while also making efforts to restore the drug supply, particularly for individuals diagnosed with type 2 diabetes.
According to NHS projections, approximately 50,000 qualified patients in England stand to benefit from Wegovy, provided through NHS specialist weight management facilities capable of offering the necessary multi-disciplinary care.
Backing the efficacy of Wegovy, Novo Nordisk presented findings from a comprehensive five-year research project titled the Select trial. The study, which incorporated 17,604 adults aged 45 and above from 41 different countries, revealed that the drug could diminish the likelihood of heart attacks or strokes in individuals with obesity harbouring cardiovascular diseases by a considerable twenty percent. Participants in this trial were characterised by a BMI exceeding 27, established cardiovascular ailments, and devoid of any diabetes history.
Read MoreNovo Nordisk’s weight-loss drug Wegovy demonstrates heart benefits in latest trial
Novo Nordisk’s groundbreaking obesity drug, Wegovy, has been shown to offer significant cardiovascular advantages, according to the results of a major late-stage trial announced on Tuesday (8th of August, 2023). This revelation not only highlights the efficacy of the medication but also helps in reshaping its perception beyond merely being a lifestyle drug.
The clinical study, named SELECT, revealed that individuals treated with Wegovy experienced a 20% reduction in the occurrence of heart attack, stroke, or death from heart-related diseases, in comparison to those who were administered a placebo. These findings far exceed the 15-17% reduction that had been anticipated by investors and analysts, although it’s worth noting that the results have not yet been subject to peer review.
Involving a substantial cohort of 17,500 participants, the SELECT trial specifically targeted individuals with overweight or obesity aged 45 or older, with a history of heart disease, but without prior diagnosis of diabetes. The trial, which spanned nearly five years, aimed to determine whether Wegovy’s weekly injection could confer tangible medical advantages.
The announcement of these positive results led to a surge in Novo Nordisk’s shares, propelling them by more than 13% to record highs. Over the past two years, the company’s shares have skyrocketed by almost 150%.
These encouraging outcomes could potentially influence insurers in the U.S. and health authorities in Europe to extend coverage of Wegovy to a broader segment of patients. Currently, some healthcare plans, including the U.S. Medicare health plan, categorise weight-loss treatments as lifestyle drugs. Experts opine that the new data might lead to a reassessment of this stance, particularly in the U.S., where the cost of Wegovy stands at $1,300 per month.
The findings from the trial have also prompted discussions regarding the long-term health benefits of the drug, particularly in terms of potentially lowering the overall healthcare burden and the expenses associated with treating heart disease in populations with overweight or obesity. Some experts, like Dr. Jeff Levin-Scherz, a consultant at Willis Towers Watson, remain cautious, suggesting that medical cost savings might be years away. He postulates that the drugs may prove to be cost-effective in improving patients’ lives but may not necessarily reduce their overall healthcare costs.
Large American corporations, which previously covered weight-loss treatments for their employees, have reduced their support due to escalating costs. However, the landmark data from the SELECT trial illustrates Wegovy’s potential to redefine how obesity is perceived and treated, according to Martin Holst Lange, Novo Nordisk’s executive vice president for development.
Novo Nordisk has expressed plans to submit applications for regulatory approvals of a label indication expansion for Wegovy in the U.S. and the European Union within the year.
Wegovy has already had a transformative impact on the weight-loss market since its U.S. introduction in June 2021. It has not only garnered attention from patients, investors, and celebrities around the globe but also significantly contributed to Novo’s shares’ growth. The injection helps patients feel fuller for more extended periods, resulting in an average weight loss of around 15% when coupled with dietary and exercise changes. The drug is part of the GLP-1 agonists class, initially developed to treat type 2 diabetes.
With obesity affecting over 650 million adults globally, a figure that has tripled since 1975, and approximately another 1.3 billion classified as having overweight, the World Health Organization links these conditions to heightened risks of heart disease and diabetes.
Industry analysts, like Sydbank’s Soren Lontoft Hansen, are optimistic that these better-than-expected results will cause a stir among physicians who prescribe anti-obesity drugs. Furthermore, Barclays analysts project that a positive outcome from the study could boost Wegovy’s uptake by 25% by 2030, provided it receives approval for expanded use.
Novo Nordisk is currently facing challenges to meet the soaring U.S. demand for Wegovy. In May, the company announced it was cutting the supply of starter doses to the U.S. market by half to secure supplies for existing patients. Although larger doses were reported to be in short supply by Reuters, Novo has denied such claims.
The detailed data from the trial is scheduled to be presented at a scientific conference later in 2023, and additional details may be revealed when Novo releases its second-quarter results on Thursday.
Read MoreBoehringer Ingelheim joins the obesity drug race, unveiling promising results
Boehringer Ingelheim has joined the race for the next generation of obesity drugs, as a recent trial revealed that its treatment helped participants on the highest dose shed an impressive 19% of their body weight.
With its sights set on launching a late-stage trial, Boehringer Ingelheim aims to compete against Eli Lilly’s Mounjaro and Novo Nordisk’s Wegovy in the obesity drug market. Other players, including Pfizer and Regeneron, are also vying to enter the fray.
While direct comparisons are challenging, previous results demonstrated that participants on Mounjaro achieved an average weight loss of 22.5%, while Wegovy study patients experienced around 15% weight reduction.
Boehringer Ingelheim believes that extended use of its drug, as indicated by the continuous weight loss observed in its 48-week trial, could yield even greater results in terms of weight loss during the phase 3 trial, which is currently being discussed with regulatory authorities.
Paola Casarosa, Head of Therapeutic Areas at Boehringer Ingelheim, expressed confidence in observing “an even stronger effect” in the larger and longer phase 3 trial, highlighting the absence of any plateauing of effects as an encouraging finding.
The introduction of the first two obesity drugs has dramatically transformed the fortunes of the pharmaceutical companies involved. Novo Nordisk’s shares have skyrocketed by 247% in the past five years, while Eli Lilly has become the world’s largest pharmaceutical company by market capitalization on the back of hopes for its obesity and Alzheimer’s drugs.
Meeting the surge in demand driven by celebrity endorsements and the use of similar drugs for weight loss in diabetics has posed challenges for these companies. According to the World Health Organization, global obesity rates have tripled since 1975, and a Harvard study predicts that nearly half of Americans will have obesity by 2030.
Boehringer Ingelheim’s survodutide, developed in collaboration with Danish biotech Zealand Pharma, functions by mimicking a hormone called GLP-1 to reduce appetite, similar to existing drugs. However, survodutide also mimics glucagon, a hormone known to accelerate the rate at which the body burns energy.
Casarosa emphasised the importance of finding the right balance, stating that meaningful and impactful weight loss relies on the interplay between food intake and metabolism adjustment.
Moreover, the drug shows potential in addressing fat accumulation in the liver, a condition affecting 70% of patients with obesity and associated with diabetes and cardiovascular problems.
However, approximately a quarter of trial participants dropped out due to side effects, primarily gastrointestinal in nature, akin to the nausea experienced by users of approved obesity drugs. Boehringer Ingelheim believes that such issues can be mitigated by gradually increasing the dosage in future applications.
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