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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GLP-1s, ADCs, AI and the future of pharma

Pharma’s potential breakthroughs in AI, ADCs, and GLP-1 receptor agonists raise a critical question: can innovation outpace the relentless rise of chronic disease?

The IQVIA Institute for Human Data Science sheds light on this theme, among many others, in its 80-page Global Trends in R&D 2024 report.

Pillar 1: GLP-1 receptor agonists targeting metabolic disease

Speaking of next-gen metabolic therapies in particular, Murray Aitken, the executive director of the IQVIA Institute for Human Data Science, sees significant potential. Market projections for GLP-1 drugs are bullish, with some analysts projecting sales potentially hitting $100 billion by 2030. “It’s exciting because if the market for these drugs becomes as big as anticipated, it means they are truly being disruptive in a positive way to human health for hundreds of millions of people worldwide,” said Aitken

New metabolic therapies are sorely needed as the obesity epidem…

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Beyond diabetes and obesity: Can GLP-1 therapies also transform chronic disease treatment?

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Glucagon-like peptide-1 (GLP-1) receptor agonists like semaglutide and tirzepatide have cemented their status as two of the most successful drugs in recent memory. Recent projections have estimated that the drug class could fetch $44 billion by 2030 and $71 billion by 2032.

But GLP-1 sales could potentially reach greater heights as these therapies move beyond their established territories of diabetes and obesity and start tackling major conditions like chronic liver and kidney disease, Alzheimer’s disease, and heart failure.

Promising clinical trial results highlight the potential of GLP-1s in an array of disease, including chronic kidney disease, nonalcoholic steatohepatitis (NASH), various forms of heart failure and potentially even Alzheimer’s.

There are, however, hurdles, such as a relatively high rate of gastrointestinal (GI) side effects, which affect somewhere around 40–7…

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GLP-1 drugs could open a new frontier in NASH treatment

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This morning, Eli Lilly reported positive phase 2 results for its dual GLP-1 and GIP receptor agonist tirzepatide in patients with nonalcoholic steatohepatitis (NASH). In the SYNERGY-NASH trial, the therapy achieved NASH resolution without worsening fibrosis in 61.3% of patients. That is considerably higher than data for semaglutide.

Picturing tirzepatide’s NASH resolution in a phase 2 study

The bar graph below depicts the proportion of participants showing no worsening of liver fibrosis at 52 weeks with varying doses of tirzepatide compared to a placebo in the SYNERGY-NASH phase 2 study. See page 17 here for the data source.

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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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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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