The Gut Punch Weekly #31
Wegovy beats Zepbound in heart health, Teva launches first generic version of Saxenda, Wegovy gets new FDA approval for liver disease, and more!
Top Stories
1) Wegovy Beats Zepbound in Cardiovascular Risk Reduction Study
A real-world study found that Novo Nordisk's Wegovy significantly outperformed Eli Lilly’s Zepbound in reducing the risk of heart attack, stroke, and death among obese patients with established cardiovascular disease.
Wegovy users experienced a 57% lower risk of cardiovascular events compared to Zepbound users when accounting for consistent treatment, and a 29% reduction overall.
While Zepbound has shown greater weight loss in previous head-to-head trials, it does not yet have cardiovascular risk reduction approval, highlighting a key advantage for Wegovy.
2) Teva Launches First Generic Version of Saxenda for Obesity
Teva has launched the first generic version of Novo Nordisk's Saxenda (liraglutide), marking the debut of a generic GLP-1 treatment for obesity in the US market.
Teva has set the wholesale acquisition cost (WAC) for a monthly dose of its Saxenda generic at $1,165, slightly lower than the $1,350 WAC of the branded version.
However, sales of branded Victoza and Saxenda have significantly decreased in recent years due to the rising popularity of newer GLP-1 products like Novo's semaglutide (Ozempic, Wegovy) and Eli Lilly's tirzepatide, as well as competition from compounded products.
3) Wegovy Gets New FDA Approval For Liver Disease
Novo Nordisk has secured U.S. FDA approval for Wegovy to treat metabolic dysfunction-associated steatohepatitis (MASH), expanding the drug's potential market.
Additionally, Wegovy has gained approval for sale in China, opening up significant new opportunities in the world's most populous country.
Novo Nordisk is advancing its pipeline with promising candidates like CagriSema and amycretin, which could represent the next breakthroughs in obesity care.
GLP-1 Industry Intel
FDA Introduces 'Green List' for Safe GLP-1 Ingredients: The FDA has introduced a 'green list' for GLP-1 drug ingredients that identifies acceptable compounders using FDA-inspected facilities, while stopping short of banning compounded versions.
GoodRx, Novo Nordisk Partnership Lowers Cost of GLP-1 Drugs: GoodRx and Novo Nordisk have partnered to offer Ozempic and Wegovy at $499 per month, a significant reduction from typical monthly prices.
Physicians Foresee Swift Adoption of Wegovy for MASH Treatment: Physicians are showing strong enthusiasm for Novo Nordisk's Wegovy in the MASH market, with 65% planning to prescribe it within three months of its approval.
Chinese Firms Shift to Generics Amid Wegovy Copycat Decline: As U.S. regulators restrict compounded weight-loss drug sales, Chinese suppliers are pivoting to develop FDA-approved generics, moving away from the previous market flooding of Wegovy copycat ingredients.
Patent Loopholes Enable Widespread Semaglutide Production: Novo Nordisk's patent protection for its GLP-1 drugs has proven ineffective against US compounding pharmacies, leading to distributed production of copycat semaglutide and forcing the company to shift strategies.
Novo Tests Ozempic for Potential Alzheimer's Treatment: Novo Nordisk's upcoming clinical trial results could determine if their GLP-1 drugs like Ozempic can effectively combat Alzheimer's disease, following promising dementia data.
Remedy Meds Acquires Thirty Madison for $500 Million: Remedy Meds, a GLP-1 telehealth startup, plans to acquire health tech unicorn Thirty Madison for $500 million, creating a multi-brand metabolic health platform.
Food & Wellness Industry Intel
Keto Diet Shows Promise in Mental Health Treatment: Research suggests the ketogenic diet could be a game-changing intervention for psychiatric conditions, with case studies showing major improvements in treatment-resistant cases including anorexia nervosa.
Unproven GLP-1 Microdosing Gains Popularity for Longevity: Despite lacking scientific evidence, patients and telehealth companies are increasingly experimenting with 'microdosing' GLP-1 drugs for longevity benefits and reduced side effects.
Ozempic's Economic Impact Slashes Denmark's Growth Forecast: Denmark's economic growth forecast for 2025 has been halved due to a slowdown at Novo Nordisk, exposing the country’s deep economic ties to Ozempic.
GLP-1 Drugs' Impact on Gut Health Remains Unclear: While GLP-1 drugs show promise for weight loss and may affect gut health, experts warn about potential nutrient deficiencies and call for dietary caution.
Frontline Focus
Insurers Limit GLP-1 Drug Use Amid Rising Costs: As GLP-1 weight loss drug costs strain insurers, some are exploring 'deprescription' strategies to limit coverage duration and wean patients off medications after weight loss goals are achieved.
Insurers Block Access to Effective Obesity Drugs: CVS Caremark's decision to exclusively cover Wegovy over Zepbound reveals the shifting power from doctors to insurers regarding patient access to effective weight-loss medications.
CVS Sued Over Dropping Zepbound from Drug Coverage: A class-action lawsuit claims CVS Caremark unlawfully dropped Zepbound from its formulary, denying medically necessary coverage and ignoring differences with other GLP-1 drugs like Wegovy.
GLP-1 Drugs Reduce Carbon Emissions in Heart Failure Care: Use of GLP-1 receptor agonists for heart failure lower greenhouse gas emissions by reducing hospitalizations and calorie intake, offering environmental as well as clinical benefits.
Weight Loss Drugs More Cost-Effective as Prices Drop: A new report from drug pricing watchdog ICER indicates Ozempic and Mounjaro have become more cost-effective due to price drops and proven cardiovascular benefits.
GLP-1 Clinical Insights
Tirzepatide Effective for Obesity Due to MC4R Deficiency: A new study reveals that tirzepatide is equally effective for weight loss in people with MC4R gene deficiency as in those without the mutation.
Semaglutide Reduces Cocaine-Seeking Behavior in Rats: Semaglutide, the active ingredient in Ozempic and Wegovy, could potentially treat cocaine addiction by reducing drug-seeking behavior in rats.
The Bleeding Edge
Four-Hormone Drug Aims to Match Bariatric Weight Loss: Tufts researchers developed a novel 4-in-1 weight loss compound targeting GLP-1, GIP, glucagon, and PYY receptors, potentially offering greater efficacy than current drugs like Ozempic.
Tirzepatide Improves Mitochondrial Function in Parkinson's Study: A new study shows tirzepatide effectively treats Parkinson's disease in mice by promoting mitochondrial health and function.