Could Wegovy’s cardiovascular label expansion be a catalyst for GLP-1 obesity drug coverage?

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The recent FDA approval of a cardiovascular risk reduction indication for Wegovy (semaglutide) could point toward a significant opportunity for pharma companies seeking to reshape payer perceptions and expand coverage for next-gen metabolic therapies. This regulatory shift, allowing Wegovy to be prescribed for reducing the risk of major adverse cardiovascular events such as heart attack and stroke in addition to weight loss, aligns with mounting payer pressure to address the worsening obesity epidemic, which could impact 60% to 80% of the population of Western nations by the middle of the century. The dynamic has the potential to break down long-standing reimbursement barriers for effective yet costly medications.

Payers reckoning with the complex economics of obesity

There were already signs of change. While around 25% of employers provided coverage for GLP-1 drugs like Wegovy and Ozempic …

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How Novo Nordisk’s Wegovy cardiovascular benefits could drive further growth

Semaglutide was already one of the best-selling drugs of recent memory. And Novo Nordisk the fastest-growing Big Pharma firm. Now, the FDA’s decision to expand the label of its weight-loss version of the drug to include cardiovascular benefits could help unlock more growth momentum for Novo Nordisk. This positions Wegovy as the first weight-loss medication also cleared for reducing the risk of heart attack, stroke, or heart-related death in at-risk individuals. The approval, based on a 17,600-patient SELECT study demonstrating a 20% lower risk of cardiac events with Wegovy versus placebo, could have a material impact on sales. The study also found that patients lost an average of 15% of their weight.

The expanded FDA label sanctions the use of Wegovy for reducing the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease who are obese or overweight. This marks a significa…

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Novo Nordisk achieves 74% growth surge, clinching fastest-growing pharma title

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No longer just a diabetes company, Novo Nordisk’s semaglutide-based therapies have fueled its rise to pharma powerhouse status. From 2021 to 2023, the company cemented its position as the fastest-growing Big Pharma player, reaching a 35% year-over-year growth rate in 2023 and 74% growth from 2020 to 2023 when measured in U.S. dollars. While Pfizer saw even more explosive growth (94%) in 2021 (see second graph below), the trajectory was not sustainable leading to a 41.69% drop in 2023.

The strong demand for Novo Nordisk’s semaglutide-based products Ozempic, Rybelsus, and Wegovy fueled the company’s rapid growth. In 2023, sales of obesity care products, including Wegovy, skyrocketed by 154% to DKK 41.6 billion ($6.0 billion). The 24% sales increase in the diabetes care segment, amounting to DKK 173.5 billion ($25.2 billion) in 2023, was heavily driven by the growth of GLP-1-based pr…

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Could an ‘extreme’ hibernating ground squirrel unlock new obesity treatments?

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In late 2023, Eli Lilly, whose stock is now up close to 80% over the past year, inked a deal with the Emeryville, California–based Fauna Bio potentially worth $494 million that focuses on the discovery of novel drug targets for treating obesity. In 2020, Fauna entered into an obesity-focused collaboration with Novo Nordisk, Lilly’s primary rival in the obesity treatment market. Coincidentally, Novo Nordisk’s stock is up more than 50% over the past year, thanks in large part to strong sales of the GLP-1 drugs Ozempic and Wegovy.

In the hunt for the next obesity blockbuster, both Lilly and Novo Nordisk are turning to Fauna Bio’s expertise in extreme mammal genomics. Among Fauna Bio’s focus areas is the 13-lined ground squirrel, an example of the company’s emphasis on “extreme mammals.” The squirrels are known for their remarkable metabolic transformations during hibernation that make them…

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Zepbound helps people lose 25% of body weight on average 88 weeks, but weight regain is a concern

Lilly’s hot weight loss drug Zepbound (tirzepatide) may be one of the most effective drug therapies for weight loss. In an open-label 36-week study, participants lost an average of 20.9% of their body weight in 36 weeks. With an average weight of 107.3 kg (236.5 lbs), that equates to about 22.4 kg (49.4 lbs) on average.

Weight regain a risk for those going off Zepbound

The catch, however, is that participants needed to keep taking the drug to keep losing weight. Those who stopped taking it saw a rebound, regaining about half of what was lost in the 52-week period after the initial 36-week study. But those who kept taking tirzepatide continued losing weight — an additional 5.5% reduction from week 36 to week 88.

In general, significant weight loss followed be regain can be more than an inconvenience. A Journal of Clinical Endocrinology and Metabolism 16-year prospective cohort study looking at patients with type 2 diabetes found such fluctuations to be linked to…

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Tirzepatide beats semaglutide 3-to-1 for weight loss goals in real-world data

A new real-world study (pre-print) is the first to directly compare weight loss outcomes between the popular diabetes medications Lilly’s Mounjaro (tirzepatide) and Novo Nordisk’s Ozempic (semaglutide). The results show Mounjaro users are significantly more likely to achieve meaningful weight loss.

Analyzing data from more than 40,000 patients from a large U.S. health database, the researchers found those taking Mounjaro were nearly three times more likely to lose 10% of their body weight compared to Ozempic users. Additionally, they were also almost twice as likely to lose 5% of their weight, and three times more likely to lose 15%.

Weight Loss Thresholds Comparison google.charts.load('current', {'packages':['corechart']}); google.charts.setOnLoadCallback(drawChart); function drawChart() { var data = google.visualization.arrayToDataTable([ ['Drug', '≥5% Weight Loss', '≥10…
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AstraZeneca faces profitability dip in Q3 2023 despite revenue bump; bets big on obesity

Cambridge, UK–based AstraZeneca continued its strong growth trajectory in Q3 2023, expanding its cardiometabolic and obesity pipeline with a focus on GLP-1 receptor agonists. In particular, AstraZeneca has a licensing agreement with Eccogene for ECC5004, a potential oral GLP-1RA for obesity and cardiometabolic conditions, represents the company’s strategic focus on this emerging therapeutic area, which Lilly and Novo Nordisk currently dominate.

Pascal Soriot, CEO of the company noted he was “excited” about the acceleration of the company’s cardiometabolic and obesity pipeline with the licensing agreement for ECC5004, “a potential best-in-class oral GLP-1RA.”

ECC5004 has an oral formulation, in contrast to Novo Nordisk’s Wegovy (semaglutide) and the recently approved Lilly’s Zepbound (tirzepatide), which are injectables. This oral GLP-1 receptor agonist could potentially improve patient compliance and accessibility in treating obesity and type 2 diabetes. While …

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Lilly’s Zepbound to enter the weight management market with competitive pricing

Lilly’s tirzepatide notched an FDA approval for chronic weight management, potentially clearly the way for billions in additional sales. Analysts have projected that the drug could fetch $26 billion in annual sales by 2030, with roughly two-thirds of that sum related to obesity​ treatment​. Bank of America analyst Geoff Meacham is even more optimistic, predicting that sales could hit $48 billion annually​.

The company is calling the obesity-branded version of the drug Zepbound, in contrast to Mounjaro, which won FDA approval for type 2 diabetes on May 13, 2022.  

Lily’s stock was up 3.20% to $619.13. Year-to-date, its share price is up almost 70%, in part as a result of strong sales prospects for tirzepatide. 

The table below outlines the starting cash prices for a range of GLP-1 receptor agonists. Lilly’s Zepbound, the obesity-branded version of tirzepatide, has a competitive starting price in the segment. With insurance, Zepbound could cost as lo…

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Will GLP-1 drugs transition from obesity and diabetes to diverse clinical indications?

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The explosive sales growth of GLP-1 drugs has analysts projecting that the antiobesity drugs could be a $44 billion market by 2030. Some observers are more upbeat, projecting that the sector could be worth more than $100 billion in the coming years. Pfizer CEO Albert Bourla projects that the market will reach $90 billion by 2031 with oral GLP-1 therapies contributing to the growth, Bloomberg quoted him as saying.

But what if those figures are too low? While hurdles remain in terms of the drugs’ side effect profiles and payer backing, anti-obesity drugs could potentially find use for other conditions, concludes Truist director Dr. Joon Lee in a briefing note not specifically mentioning sales projections for the sector. In the long run, the drug class could find use not just for obesity but for conditions associated with elevated body weight. Examples run the gamut from neurodegenerative conditions s…

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Pfizer drops one weight loss drug, bets on another

Pfizer has made a strategic decision in the battle against obesity and diabetes. The pharmaceutical giant has chosen to discontinue its GLP-1 RA candidate, lotiglipron, to focus resources on the development of another – danuglipron. This Pfizer weight loss drug is now the lead candidate in late-stage trials for the treatment of obesity and diabetes. The decision comes after the discovery of elevated liver enzyme levels in some early trial patients for lotiglipron. However, similar concerns have not arisen with danuglipron.

The shift comes as the company aims to tap full receptor agonism for potential robust efficacy, capitalizing on its small molecule design expertise. With more than 1,400 patients already enrolled, the clinical trial results could potentially expand the treatment options for adults with obesity and Type 2 diabetes.

Already, GLP drugs semaglutide and tirzapatide are beginning to reshape the way we treat obesity.

Novo Nordisk’s sema…

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The battle of the bulge: Semaglutide and tirzapatide could be new weight-loss warriors

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A pair of weight-loss drugs —  semaglutide and tirzapatide — could reshape the way we view and treat obesity, according to a Moody’s report dated May 18. The ratings firm notes that Novo Nordisk could benefit from a first-mover advantage in the obesity market as it now has two novel weight loss drugs on the market: Saxenda (liraglutide) and Wegovy (semaglutide). Semaglutide has already emerged as an example of a ‘viral’ drug, as Harvard Health Publishing noted earlier this year, owing to its popularity on social media and with celebrities. A YouGov survey found that 60% of Americans had heard about this class of weight loss drugs.

If Lilly’s tirzepatide, the first dual GIP/GLP- coagonist, wins approval for obesity, its developer could also profit handsomely. In April, analysts projected that annual tirzepatide sales could hit $50 billion by 2030.

Tirzapa…

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Tirzepatide versus semaglutide: Which contender will prevail in the battle against obesity and type 2 diabetes?

Eli Lilly‘s (NYSE:LLY) tirzepatide achieved up to 15.7% weight loss in the SURMOUNT-2 study, sparking a potential tirzepatide vs semaglutide competition in the obesity and type 2 diabetes treatment markets. The phase 3 study enrolled 938 participants with diverse backgrounds.

Tirzepatide promises to be a megablockbuster with a number of analysts pegging peak annual sales hitting $25 billion. Few drugs have surpassed the $20 billion threshold. One notable example is AbbVie’s monoclonal antibody Humira (adalimumab), which hit $21.2 billion in sales in 2022 and $20.7 billion a year earlier. The drug was the world’s bestseller until the COVID-19 pandemic stoked demand for the Pfizer-BioNTech vaccine, whose cumulative annual sales hit $59.1 billion in 2021.

Lilly has signaled its plans to submit tirzepatide to the FDA, potentially leading to competition between tirzepatide and semaglutide in the obesity and type 2 diabetes treatment markets.

Tirzepatide&#…
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