semaglutide Archives - Medical Design Sourcing

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

[catalin/Adobe Stock]

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 …

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…

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

[Adobe Stock]

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…

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

[Adobe Stock]

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.

google.charts.load('current', {packages: ['corechart', 'bar']}); google.charts.setOnLoadCallback(drawChart); function drawChart() { var data = google.visualization.arrayToDataTable([ ['Treatment', 'Perc…

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…

Novo Nordisk stops once-weekly semaglutide kidney outcomes trial early following interim analysis

Novo Nordisk will halt the phase 3b FLOW trial, which investigated the effects of once-weekly injectable semaglutide on kidney outcomes in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD).

The company reached the decision following the recommendation of the independent Data Monitoring Committee (DMC), following an interim analysis that met pre-specified criteria for stopping the trial early for efficacy. The company noted that it would maintain the integrity of the trial data, blinding to the results until the trial’s completion. It plans on announcing results in the first half of 2024.

Semaglutide Sales: 2022 vs H1 2023 google.charts.load('current', {'packages':['corechart']}); google.charts.setOnLoadCallback(drawChart); function drawChart() { var data = google.visualization.arrayToDataTable([ ['Drug Name with Brand', '2022 Sales', 'H1 2023 Sales'], …

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

[Image courtesy of New Africa/Adobe Stock]

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…

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&#…

Semaglutide supply shortfall fuels demand for alternatives

Novo Nordisk (NYSE:NVO) continues to face supply shortages for its Wegovy (semaglutide) pens, which are FDA approved for weight management.

Against that backdrop, a growing number of companies have begun selling compounded versions of the drug.

Drug compounding involves “combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient,” according to the FDA. The regulatory agency does not approve compounded drugs, nor does it validate their safety, effectiveness or quality.

Novo Nordisk notes on its website that it has “become aware of an increasing trend in compounding pharmacies purporting to have availability of Wegovy or semaglutide.” The company adds that it “does not sell Wegovy (or its active ingredient, semaglutide) for the purposes of compounding with other products.” Novo Nordisk is the only company with FDA approval related to Wegovy, which is offered as a pr…

Lilly’s tirzepatide gives Novo Nordisk’s semaglutide a run for the money in Phase 3 trial

Eli Lilly and Co. (NYSE: LLY) has announced that tirzepatide enabled trial participants to lose up to 22.5% of their body weight in the SURMOUNT-1 study.

Study volunteers receiving tirzepatide lost up to 52 lb. (24 kg) in the 72-week Phase 3 trial. A total of 55% of those receiving a 10 mg dose lost at least 20% of their body weight while 63% of those on a 15 mg dose hit the same benchmark. Only 1.3% of those taking placebo had the same level of weight loss.

Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor antagonist.

It is thus broadly similar to Novo Nordisk’s semaglutide, a glucagon-like peptide 1 (GLP-1) receptor antagonist that has achieved strong growth in diabetes as Rybelsus. Demand appeared to be strong for Wegovy, an injectable semaglutide formulation that won FDA approval for supporting weight management in June 2021, but the drug has faced supply challenges in the U.S. Read more

Novo Nordisk wins FDA approval for higher-dose Ozempic for adults with type 2 diabetes

FDA has approved a 2 mg injectable dose of Novo Nordisk’s (NYSE:NVO) Ozempic (semaglutide), a once-weekly glucagon-like peptide-1 (GLP-1) analog. The indication covers improving blood sugar control and reducing the risk of cardiovascular complications in adults with type 2 diabetes when used in conjunction with diet and exercise changes.

To win the new indication, the Bagsværd, Denmark–based company provided data showing the 2 mg dose led to an average 2.1% blood glucose reduction and weight loss in adults with type 2 diabetes.

In the SUSTAIN Phase 3 clinical trial, a 1 mg dose of Ozempic helped up to 73% of people with type 2 diabetes reach the American Diabetes Association target of <7%.

Ozempic image courtesy of Novo Nordisk

The 2 mg dose could help individuals who need additional glycemic control.

“With its proven safety and efficacy, Ozempic helps deliver on blood glucose control…

Novo Nordisk settles Danish securities lawsuit

Novo Nordisk (NYSE:NVO) has settled a securities lawsuit in Denmark filed in August 2019 in the district court of Glostrup.

In 2019, Novo Nordisk vowed to fight the allegations contained in the lawsuit, which alleged that the company’s insulin-related profits fell at the same time prices and sales increased from February 2015 and February 2017. The dip in profits resulted from an uptick in rebates to pharmacy benefit managers.

Investors behind the suit claimed that Novo Nordisk had exaggerated its U.S. insulin revenue in this time period.

In the settlement, the Bagsværd, Denmark–based company did not admit any liability or wrongdoing.

The lawsuit was related to several shareholders alleging that Novo Nordisk did not appropriately disclose facts related to its U.S. sales of insulin products. The shareholders initially sought DKK 11,785,192,218 (approximately $1.8 billion) in damages.

NVO shares have fallen steadily in January 2022 in …