Eli Lilly’s Tirzepatide shows up to 66% reduction in sleep apnea severity in adults with obesity
In a recent development, Eli Lilly & Co. announced that its weight-loss medication, Tirzepatide, has shown promising results in alleviating symptoms of obstructive sleep apnea, a disorder primarily associated with obesity. This revelation emerged from two advanced clinical trials, wherein Tirzepatide significantly reduced the incidences of diminished or halted breathing during sleep by up to 63%, surpassing the anticipations of Jefferies analysts who had projected a reduction range of 50% to 55%.
During these year-long studies, participants experienced a substantial decrease in body weight, with losses nearing 20%, as reported by Lilly. The pharmaceutical giant intends to present the comprehensive findings from these studies at the upcoming American Diabetes Association conference in June. Subsequently, plans are underway to submit these results to the U.S. Food and Drug Administration and other international regulatory bodies starting mid-year.
The potential approval of Tirzepatide for treating sleep apnea could significantly broaden patient access to the drug through insurance coverage. Currently, weight loss medications like Tirzepatide do not receive coverage under Medicare, the U.S. federal health programme for the elderly and certain individuals on long-term disability. Such approval would not only facilitate greater competition with Novo Nordisk A/S—whose leading weight-loss drug, Wegovy, has recently gained insurance coverage for some Medicare beneficiaries with cardiac conditions—but also position Lilly at the forefront of addressing the underlying causes of sleep apnea.
Jeff Emmick, Lilly’s senior vice president of product development, emphasised the transformative potential of Tirzepatide, highlighting its capacity as the inaugural pharmaceutical intervention targeting the fundamental aspects of the disease. Given the correlation between weight loss and improvements in sleep apnea symptoms, widespread insurance coverage for Tirzepatide could potentially prevent up to 5.6 million cases of this sleep disorder by 2030, as estimated by analytics firm Airfinity.
Nevertheless, despite these advances, analysts from Airfinity caution that while GLP-1 drugs like Tirzepatide will significantly reduce sleep apnea incidences, they are unlikely to eradicate the disorder entirely.
The study enrolled 469 participants suffering from obesity and sleep apnea, with some receiving Tirzepatide alone and others receiving both the drug and using breathing devices. Results indicated a more pronounced average reduction in the apnea-hypopnea index (AHI)—a diagnostic measure quantifying the severity of sleep apnea based on the number of breathing disruptions per hour of sleep—for those utilising both the medication and breathing devices compared to those solely on medication.
The approval of Tirzepatide for sleep apnea treatment could also influence the market for respiratory support devices. Companies like ResMed Inc. and Inspire Medical Systems Inc., which manufacture such equipment, may see a reduction in demand, with Airfinity projecting a potential market contraction of over 11% in the coming years due to the increased use of weight loss drugs as a therapeutic alternative.
Read MoreEuropean regulators find no evidence of link between new obesity medication and suicidal thoughts
Following an extensive nine-month investigation, European medical regulators have concluded that there is no evidence to suggest that GLP-1 receptor agonists, such as Ozempic and Wegovy, contribute to suicidal ideation or behaviours. This conclusion by the European Medicines Agency (EMA) aligns with a similar assessment conducted by the U.S. Food and Drug Administration (FDA) earlier in January, which also found no causal connection between these widely used medications for weight loss and diabetes and the risk of suicidal thoughts.
The investigation by the EMA began in July, 2023, after anecdotal instances were reported where patients exhibited self-harm thoughts while being treated with GLP-1 receptor agonists, specifically liraglutide (marketed as Saxenda by Novo Nordisk) and semaglutide (known commercially as Ozempic and Wegovy, also by Novo Nordisk). The concern prompted the EMA’s Pharmacovigilance Risk Assessment Committee to demand further information from the manufacturers of these medications in November.
Throughout the investigation, the committee meticulously analysed various sources including medical records, clinical trial data, post-marketing surveillance reports, and other academic studies. Notably, a study published in Nature Medicine indicated that the risk of suicidal ideation was actually lower in patients using GLP-1 drugs compared to those treated with other medications for obesity and diabetes. Ultimately, the EMA committee concluded that the evidence does not support a causal link between the use of GLP-1 receptor agonists and increased suicidal risk.
Despite these findings, the EMA has mandated continuous monitoring by manufacturers of GLP-1 based medications for any future incidents of suicidal thoughts or actions. This ongoing vigilance reflects a cautious approach, particularly given the historical context where earlier obesity treatments, such as rimonabant, were withdrawn from the European market in 2008 due to their association with increased suicidal ideation risks.
GLP-1 based treatments, including Ozempic, Wegovy, Eli Lilly’s Mounjaro, and Zepbound, have seen a surge in popularity recently. However, this increase in usage has coincided with sporadic anecdotal reports linking the drugs to suicidal thoughts, thus prompting these detailed investigations.
The FDA, in its preliminary review statement in January, mentioned that while a definitive exclusion of any risk is challenging, it is committed to further investigation to clarify this potential link. It is important to note that while the FDA’s approvals for Wegovy and Zepbound for obesity management include advisories for physicians to monitor for signs of suicidal thoughts, similar advisories are not included on the labels of Ozempic and Mounjaro, which are approved for managing type 2 diabetes.
This comprehensive review by regulatory bodies underscores a significant step in ensuring the safety and efficacy of GLP-1 medications, reaffirming their use in clinical practice amidst growing concerns over possible psychiatric side effects.
Read MoreArtificial intelligence discovers potential plant extracts for obesity treatment
In an innovative study utilising artificial intelligence (AI), researchers have identified two plant-based compounds with the potential to act as GLP-1 agonist weight loss medications. This significant finding will be presented at the European Congress on Obesity (ECO 2024), set to take place in Venice from 12th to 15th May, 2024.
GLP-1 (Glucagon-like peptide-1) receptor agonists, such as semaglutide and tirzepatide, have proven highly effective in aiding weight loss. These agents work by emulating the effects of the GLP-1 hormone, which interacts with receptors in cells to diminish appetite and hunger sensations, decelerate gastric emptying, and enhance satiety following meals.
Despite their efficacy, the quest for alternatives is imperative, according to Elena Murcia from the Structural Bioinformatics and High-Performance Computing Research Group (BIO-HPC) & Eating Disorders Research Unit at the Catholic University of Murcia (UCAM), Spain. She notes the presence of side effects associated with current GLP-1 agonists, including gastrointestinal discomfort and mental health fluctuations, such as anxiety and irritability. Moreover, discontinuation of these treatments often leads to weight regain.
A significant limitation of current GLP-1 agonists, which are peptide-based, is their susceptibility to degradation by stomach enzymes, necessitating administration via injection rather than oral intake.
The search for non-peptide alternatives has recently identified two promising synthetic compounds, TTOAD2 and orforglipron. However, Murcia and her team are driven to discover natural counterparts that might offer similar benefits with potentially fewer side effects and simpler administration methods.
Employing high-performance AI techniques, the team embarked on a quest to identify non-peptide, plant-derived compounds capable of activating the GLP-1 receptor. Their investigation began with a virtual screening of over 10,000 compounds, aiming to pinpoint those that could bind to the GLP-1 receptor. Subsequent AI analyses assessed the similarity of these bonds to the natural interaction between the GLP-1 hormone and its receptor. This led to the selection of 100 compounds for further visual scrutiny to evaluate their interaction with crucial receptor residues.
A mathematical approach involving Venn diagrams helped distil the search to 65 potential GLP-1R agonists, among which “Compound A” and “Compound B” showed strong binding affinity to critical receptor sites, akin to the synthetic compounds TTOAD2 and orforglipron.
These compounds, derived from commonly known plants with historically recognised metabolic benefits, are currently under laboratory examination. Pending patent approvals, further specifics about these plants and compounds remain confidential, with aspirations for future pill-form administration.
Murcia highlights the nascent stage of developing these natural source-derived GLP-1 agonists. Should the AI-predicted efficacy be validated through in vitro studies and subsequent clinical trials, these compounds could offer new therapeutic avenues for obesity management.
She further emphasises the advantages of computer-based research methodologies, including cost and time efficiency, the capacity for rapid large-scale data analysis, experimental design flexibility, and pre-emptive ethical and safety risk assessments. These simulations exploit AI capabilities to tackle complex challenges, providing invaluable preliminary insights in the quest for novel pharmaceutical solutions.
Read MoreWeight-loss pharmaceuticals could spur 1% increase in US GDP, Goldman Sachs suggests
In a recent analysis, Goldman Sachs posits that the extensive deployment of innovative weight-loss medications across the United States has the potential to catalyse a significant uplift in the country’s Gross Domestic Product (GDP) by as much as 1% in the forthcoming years. This optimistic forecast is grounded in the anticipation that a reduction in obesity-related health issues could substantially enhance productivity within the workforce.
The market for these weight-loss medications is anticipated to burgeon, potentially reaching a staggering $100 billion annually by the decade’s end. Leading this burgeoning sector are pharmaceutical giants such as Novo Nordisk, the manufacturer of Ozempic, and Eli Lilly, the producer of Mounjaro. Both companies are at the forefront of developing a category of drugs known as GLP-1 agonists, which have garnered significant interest from various pharmaceutical firms. The projections by Goldman Sachs suggest that consumer uptake of GLP-1 agonists could surge, varying from 10 million to an ambitious 70 million by the year 2028.
The economists at Goldman Sachs elaborate on the potential economic ramifications of this increase in GLP-1 usage, linking it directly to anticipated declines in obesity rates. Citing academic research, they highlight the dual challenge posed by obesity: affected individuals are less likely to be employed and exhibit lower productivity levels when they are in the workforce. According to their analysis, an increase to 30 million users of weight-loss drugs could potentially boost the US GDP by 0.4%, with the potential for a 1% increase if user numbers reach 60 million.
However, the report has not been without its critics, especially from advocates of the body-positivity movement, who may view the report’s implications with scepticism or concern.
Moreover, the report underscores a broader wave of healthcare innovation, particularly highlighting the role of artificial intelligence (AI) in drug discovery processes, combined with the impact of GLP-1 agonists. Together, these advancements could elevate the US GDP by an additional 1.3%, translating to an economic boost of approximately $360 billion per annum at current exchange rates. The potential increase could range from 0.6% to 3.2%, with the effects expected to be more pronounced in the US compared to other developed nations, which generally exhibit better health outcomes.
In parallel, research into weight-loss drugs is expanding to explore their efficacy in treating a range of conditions, from alcohol dependency to dementia. Medications such as Ozempic and Wegovy, which contain the drug semaglutide, and another medication, liraglutide, used under various brand names for both diabetes and weight loss, have seen a surge in popularity. This is partly due to their proven capability to assist individuals in shedding more than 10% of their body weight. The potential for these drugs to confer additional health benefits is being actively investigated in new clinical trials, signalling a promising horizon for medical research and public health.
Read MoreThe delicate balance of preserving muscle mass in the age of weight loss pharmaceuticals
As the global population turns increasingly towards medications like Ozempic for weight loss solutions, a growing concern has emerged regarding the side effect of muscle loss associated with these treatments. This phenomenon has sparked a multifaceted response from various sectors aiming to mitigate this undesired outcome, thereby enhancing the overall health benefits of weight management efforts.
Luxury fitness centres are now tailoring strength-training regimes specifically for individuals utilising these medications, with the promise of maximising health results. These programmes are designed not just to counteract muscle degradation but to optimise the physical wellness journey of their clients. Concurrently, nutritional experts and bespoke meal delivery services are stepping up to formulate high-protein diet plans that support muscle maintenance amidst weight loss.
Pharmaceutical giants, including Eli Lilly, are at the forefront of innovation, developing drugs that offer a dual approach to weight loss by facilitating fat reduction while safeguarding or even augmenting muscle mass. Eli Lilly’s collaboration with BioAge Labs on the experimental compound azelaprag exemplifies this cutting-edge research. Azelaprag seeks to mimic the effects of exercise-induced hormones that play a critical role in muscle metabolism, offering hope for a more balanced fat-to-muscle loss ratio in patients taking drugs like Mounjaro and Zepbound.
Further expanding its arsenal, Eli Lilly’s acquisition of Versanis Bio introduces a novel approach to muscle preservation through bimagrumab, a drug that targets receptors involved in muscle and fat regulation. This promising development is backed by research suggesting enhanced muscle growth upon receptor blockade.
Clinical trials are also exploring combinations of existing weight loss drugs with new treatments to address the muscle loss conundrum. One such study involves the pairing of bimagrumab with semaglutide, the active ingredient in Ozempic, to investigate its potential in mitigating frailty in adults with obesity. Additionally, the FDA’s recent approval of a trial for a compound aimed at older adults signifies a proactive approach to preventing muscle deterioration alongside fat loss in this vulnerable demographic.
Despite the promise of these emerging treatments, their availability to the general public is anticipated to be several years away. This delay underscores the importance of immediate, accessible strategies for muscle preservation. Experts highlight the critical nature of maintaining muscle integrity, especially for older adults and postmenopausal women, who face a higher risk of frailty and osteoporosis with muscle loss. The consensus among healthcare providers is that a combination of protein-rich diets and strength training exercises remains a fundamental remedy against muscle depletion.
Capitalising on this need, companies are introducing products and services tailored to individuals on weight loss medications. From protein shakes designed to complement these drugs to specialised fitness programmes and nutritional counselling aimed at enhancing protein intake and mitigating malnutrition risks, the market is rapidly adapting.
Innovative telehealth solutions like Noom’s Muscle Defense programme, which integrates fitness guidance with dietary tracking, and fitness platforms such as Obé Fitness’s MuscleGuard, exemplify the digital response to this challenge. Additionally, initiatives like LifeTime Fitness’s clinic pilot in Minnesota, which combines personalised training with access to compounded weight loss medications, signal a growing trend towards holistic health solutions that encompass both pharmaceutical and lifestyle interventions.
While specialised programmes offer valuable support for muscle preservation, the essence of combating muscle loss lies in fundamental lifestyle adjustments. Incorporating moderate strength training and a balanced, protein-rich diet into one’s routine can be a pragmatic and effective strategy for those navigating the complexities of weight loss medications.
Read MoreEli Lilly launches digital health platform LillyDirect for obesity, migraine, and diabetes care
Eli Lilly and Company, a renowned pharmaceutical entity, has unveiled LillyDirect, an advanced digital healthcare platform primarily designed to aid patients in the United States with obesity, migraine, and diabetes management. The official announcement, made on January 4, 2024, marks a significant stride in the field of digital healthcare.
LillyDirect emerges as a multifaceted tool, offering comprehensive services that encompass disease management, support mechanisms, and a streamlined process for medication delivery. A key component of LillyDirect is the LillyDirect Pharmacy Solutions. This feature strategically links users to an external online pharmacy service, simplifying the process of obtaining prescribed medications. This innovation aims to enhance consistency in medication adherence, thereby improving patient health outcomes.
David A. Ricks, the Chairman and CEO of Lilly, expressed the company’s intent behind this launch, emphasising the simplification of the patient experience in a complex healthcare landscape. The underlying goal of LillyDirect is to alleviate patient burdens associated with chronic disease management, ultimately leading to improved health results. LillyDirect presents a novel approach to healthcare access, including a convenient option for home delivery of prescribed Lilly medications, thereby bridging the gap between patients and essential medical resources.
LillyDirect goes beyond just medication provision. It serves as a valuable resource for patients, offering access to a wealth of information and educational materials pertinent to their health conditions. This aspect of the platform enhances patient understanding and engagement with their healthcare journey.
Furthermore, LillyDirect expands the scope of patient support by integrating telehealth services. These digital consultations complement the care provided by patients’ primary healthcare teams. Additionally, the platform facilitates the search for in-person healthcare providers, thereby ensuring comprehensive care management.
Frank Cunningham, Lilly’s Group Vice President of Global Value and Access, highlighted the growing reliance on digital solutions in various aspects of daily life, including healthcare. LillyDirect is envisioned as an innovative solution that caters to the evolving needs of patients, offering an integrated experience in managing health and accessing medications. This initiative reflects Lilly’s commitment to enhancing the quality of life for patients, enabling them to focus on their personal and professional pursuits.
Read MoreFDA issues alert on counterfeit semaglutide products in the U.S.
The U.S. Food and Drug Administration (FDA) has recently issued a crucial warning to adults with diabetes in the United States about the presence of counterfeit semaglutide in the country’s drug supply chain. This alert comes following an ongoing FDA investigation into the distribution of fake versions of the 1 mg subcutaneous semaglutide, known commercially as Ozempic and manufactured by Novo Nordisk.
The FDA’s investigation has led to the seizure of thousands of units of these counterfeit products. Key identifiers of the fake medication include lot number NAR0074 and serial number 430834149057. These specific batches have been confirmed as counterfeit and are advised not to be used.
A further cause for concern highlighted by the FDA is the discovery of counterfeit needles accompanying the medication. The sterility of these needles cannot be assured, posing a heightened risk of infection for users. Additional counterfeit components identified by the FDA include the pen label, health care professional and patient information leaflets, and the packaging box.
The FDA is urging wholesalers, retail pharmacies, healthcare providers, and patients to diligently check their semaglutide products’ lot and serial numbers. While the FDA, in partnership with Novo Nordisk, is currently conducting tests on the seized counterfeit products, there is yet no comprehensive information about the content, quality, or safety of these fakes.
To date, the FDA has received reports of five adverse events associated with the use of these counterfeit semaglutide products. These incidents align with the typical side effects of authentic semaglutide, and thankfully, none of the reported cases have been serious. The FDA encourages reporting of any adverse events through its MedWatch Safety Information and Adverse Event Reporting Program, either via online submission or fax at (1-800) FDA-0178.
The FDA advises pharmacies to source genuine semaglutide only through Novo Nordisk’s approved distributors. Patients should obtain the drug strictly with a valid prescription from state-licensed pharmacies and are advised to inspect the product thoroughly for any signs of counterfeiting before use. Any suspicions or discoveries of counterfeit products should be promptly reported to the FDA. This can be done by calling the local FDA consumer complaint coordinator or by reporting directly via the FDA’s official website.
Read MoreInnovative vibrating pill may combat obesity by inducing satiety
Researchers at the Massachusetts Institute of Technology, led by Giovanni Traverso, have developed an innovative approach to tackling obesity using a vibrating pill. This method promises a less invasive alternative to gastric bypass surgery and aims to be more cost-effective and less prone to side effects than current pharmacological treatments like Wegovy and Ozempic.
The pill, approximately the size of a standard multivitamin tablet, contains a vibrating motor powered by a small, ingestible silver oxide battery. Upon reaching the stomach, the pill’s outer layer is dissolved by gastric acid, triggering an electronic circuit that activates the vibration.
In a pivotal experiment involving pigs, it was observed that those administered the pill 20 minutes before mealtime consumed roughly 40% less food than their counterparts who did not receive the pill. Additionally, these pigs exhibited elevated levels of blood hormones typically associated with satiety.
Traverso and his team are optimistic about commencing human trials soon, given the prevalent issue of obesity, which affects over 40% of the population in the United States alone. The pill works by stimulating receptors that sense stomach expansion post a substantial meal, thereby sending fullness signals to the brain.
The current prototype of the pill is designed to vibrate for a duration of 30 minutes before the battery depletes, after which it is naturally excreted from the body. Traverso envisions future iterations of the pill that could remain semi-permanently in the stomach, with the ability to be wirelessly activated or deactivated as needed. This individualised response could lead to daily automatic activation to reduce overall appetite or even manual control via a smartphone app to address specific hunger cues.
This research builds upon previous findings by the same team, which discovered that electrical stimulation of the stomach lining can induce hunger. Such findings open the door to potential treatments for appetite loss in individuals with conditions like cancer. Traverso expresses excitement about the possibilities of manipulating different parts of the gastrointestinal tract to replicate the sensation of fullness, posing the question of whether it is possible to create an illusion of satiety through such stimulation.
Read MoreNew machine learning approach transforms behavioural health medication practices
At the recent AMCP Nexus 2023 conference in Orlando, Florida (16th-19th of October), presenters showcased a groundbreaking machine learning program designed to address medication-related issues in individuals with behavioural health conditions. This program has shown promising results in reducing polypharmacy, enhancing medication adherence, and decreasing healthcare costs.
Behavioural health conditions pose a significant challenge to healthcare systems. A 2020 Milliman study examining commercial healthcare claims data from 2017, which encompassed 21 million people, revealed that although only 27% had a behavioural health condition, they accounted for over half of the total healthcare expenditures. In this context, machine learning offers a potential solution for better managing these conditions.
The presenters highlighted the issue of polypharmacy, a common concern in behavioural health where 60% of adults with a condition are prescribed two or more psychotropic medications. Polypharmacy not only increases the risk of drug interactions and adverse events but also contributes to soaring healthcare costs. Dr. Caroline Carney, Chief Medical Officer at Magellan Health, underscored the tendency for medication overlap and overprescription in treating conditions like depression and anxiety, often leading to unnecessary medication layers.
Another issue in managing behavioural health medications is the multiple prescribers involved, including primary care doctors, specialists, and inpatient clinicians, often resulting in uncoordinated treatment. This lack of coordination can leave patients confused and overwhelmed with their medication regimens.
To combat these challenges, Magellan Health collaborated with Arine, a medication management tech startup, to create inforMED (formerly known as Navigate Whole Health). This AI-driven program identifies prescribers who can potentially optimise patient care, generating comprehensive care plans with treatment recommendations and patient education. The program’s effectiveness is continuously improved by incorporating new clinical outcome data.
Dr. Carney elaborated on the program’s approach, which considers hundreds of parameters, providing prescribers not just with medication change suggestions but also with reasons, implications, and evidence-based support for the recommended changes.
Yoona Kim, PharmD, PhD, co-founder and CEO of Arine, explained that machine learning algorithms are utilised to target prescribers based on their prescribing patterns and the presence of prescribing outliers in their patient panels. The program also considers social determinants of health, using ZIP code data to assess potential barriers to healthcare access, such as low income or lack of vehicle access.
The results of this program have been significant. Dr. Kim reported a reduction in behavioural health polypharmacy by 45% to 55%, a 20% increase in medication adherence, a 20% reduction in average daily morphine milligram equivalents, and a savings of $360 to $840 in pharmaceutical costs per enrolled member annually.
Dr. Carney emphasised the program’s success in providing actionable data and guidance to healthcare providers, leading to improved patient outcomes and stronger, longer-lasting professional relationships. This innovative approach signifies a major step forward in the management of medication for behavioural health conditions.
Read MoreSwiss pharmaceutical giant Roche enters obesity drug race with $2.7 billion Carmot deal
Swiss pharmaceutical giant, Roche, has announced a significant strategic move in the obesity treatment market with its $2.7 billion acquisition of Carmot Therapeutics, a U.S.-based obesity drug developer. This places Roche among leading contenders like Novo Nordisk and Eli Lilly in the weight-loss drug sector. Carmot’s flagship product, CT-388, a once-a-week dual GLP-1/GIP receptor agonist injection similar to Lilly’s Mounjaro, has shown promise in Phase I trials and is poised for Phase II testing. Its market introduction is anticipated in the 2030s.
The move has generated optimism, reflected in a 2.4% rise in Roche shares, as the weight-loss drug market, potentially worth $100 billion, appears to have room for multiple players. Roche’s Teresa Graham, head of the pharmaceuticals division, expressed ambitions beyond merely competing on price, envisioning CT-388 as a leading obesity drug in its class.
This acquisition marks Roche’s re-entry into the GLP-1 field, following a previous exit in 2018 when subsidiary Chugai sold experimental drug rights to Lilly. The Carmot deal, expected to conclude in early 2024, includes additional payments of up to $400 million subject to achievement of certain milestones.
The deal is part of Roche’s broader strategy, under new CEO Thomas Schinecker, to diversify its therapeutic fields and rejuvenate its development pipeline, especially after setbacks in Alzheimer’s and cancer immunotherapy. Besides the Carmot acquisition, Roche recently committed $7.1 billion for rights to a new drug for inflammatory bowel disease.
Carmot, founded in 2008, has a portfolio of various gut-hormone drug candidates, in both pill and injectable forms, designed to treat obesity in patients with and without diabetes. This acquisition underlines Roche’s commitment to expanding its presence in the evolving field of obesity treatment.
Read MoreJapan’s healthcare system to include new obesity treatment in insurance coverage
Japan’s healthcare system is set to introduce a novel obesity treatment covered by public medical insurance starting Wednesday (22nd of November, 2023), marking the first such inclusion in thirty years. Wegovy, produced by the Danish firm Novo Nordisk, will be accessible under the national health insurance following its approval for manufacture and sale in March.
The treatment contains semaglutide, a GLP-1 receptor agonist that not only enhances insulin production and lowers blood sugar but also suppresses appetite by inducing satiety and curbing cravings.
Coverage is specifically tailored for patients who are significantly overweight or have weight-related health complications such as high blood pressure, hyperlipidemia, and Type 2 diabetes, and who have not seen results from lifestyle changes alone. Criteria for eligibility include having a Body Mass Index (BMI) of 35 or above, or a BMI of 27 with associated comorbidities.
Wegovy is administered weekly through self-injection, with a monthly supply consisting of four pens. The cost varies according to the dose, from ¥1,876 (£9.99) for the smallest dose to ¥10,740 (£57.19) for the highest.
The drug joins Ozempic, also a GLP-1 receptor agonist with semaglutide by Novo Nordisk, on the market. While Ozempic targets Type 2 diabetes at lower doses, Wegovy is dosed higher specifically for weight loss.
Despite its medical purposes, there’s growing concern over Wegovy’s use for aesthetic weight loss, leading to potential drug shortages for those in medical need. This has prompted Japanese medical bodies to warn against such misuse, especially with the trend of “medical diets” offered by clinics to individuals without obesity or diabetes.
Research has pointed out the risk of severe gastrointestinal issues with these medications, a concern highlighted in the Journal of the American Medical Association. Yet, Novo Nordisk has cited an August report claiming Wegovy can cut the risk of major adverse cardiovascular events by 20% in adult individuals with overweight or obesity.
Previously, Japan’s insured treatment for obesity was limited to Mazindol, introduced in 1992, designated for severe obesity and capped at three months of use due to addiction risks.
Read MoreNovo Nordisk’s $2.3 billion French investment to enhance obesity drug output
Novo Nordisk has declared a substantial $2.3 billion investment aimed at amplifying the output of its highly sought-after obesity and diabetes medications at its Chartres facility in France, in a move to satiate the escalating demand. This financial injection will notably enhance the manufacturing capabilities for existing products such as Ozempic and Wegovy, alongside other burgeoning obesity treatments, according to the Danish pharmaceutical giant.
Europe is currently grappling with a supply crisis of the diabetes medication Ozempic, which shares the active ingredient semaglutide with the widely acclaimed weight management drug Wegovy—yet to be broadly distributed across Europe.
In response to the off-label consumption of Ozempic, Novo Nordisk has imposed restrictions within the European Union. Concurrently, Germany is considering export prohibitions, while Belgium has already enacted a ban on prescribing the weekly injection for non-diabetes purposes.
Despite efforts by the UK government to restrict the use of Ozempic to non-weight loss purposes in July, a Reuters investigation discovered the drug is still being acquired by individuals without diabetes for weight management.
This announcement follows Novo Nordisk’s recent proclamation of a $6 billion expenditure in Denmark to augment production capabilities. Additionally, this venture represents a significant endorsement for French President Emmanuel Macron’s economic strategies amidst a looming global downturn, aiming to sustain the momentum in reducing French unemployment figures.
President Macron had advocated for this investment during his “Choose France” summit, which reportedly persuaded Novo Nordisk’s CEO Lars Fruergaard Jorgensen to commit to the expansion. The investment also echoes Eli Lilly’s recent decision to construct a $2.5 billion manufacturing plant in Germany, similarly motivated by heightened demand for diabetes and obesity treatments.
Analysts predict the obesity drug market could reach a staggering $100 billion by 2030. Novo Nordisk’s French investment will notably expand its capacity for intricate manufacturing processes, specifically the intricate filling of injection pens with semaglutide, and the subsequent assembly and packaging of these pens.
Though details were scant earlier this month regarding the augmentation of in-house production for Ozempic and Wegovy’s European variant, Novo Nordisk has confirmed that the Chartres expansion has commenced, with completion slated between 2026 and 2028, promising the creation of 500 new job opportunities, adding to the near 2,000-strong workforce currently employed at the factory.
Read More