semaglutide Archives - Medical Design Sourcing

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 …

Novo Nordisk faces Wegovy supply challenges in US

Novo Nordisk (NYSE:NVO) announced that one of its contract manufacturers filling syringes for its Wegovy (semaglutide) pens in the U.S. market has temporarily ceased manufacturing following Good Manufacturing Practices problems.

The company projects it will be unable to meet U.S. demand for the drug in the first half of 2022 and that use of the drug will likely be constrained to a limited number of patients.

NVO shares dipped 8.21% to $107.45 today.

Novo Nordisk anticipates a resolution of the supply shortage by the second half of 2022.

The obesity drug Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for patients with a body mass index of 30 kg/m2 or greater or 27 kg/m2 or greater (overweight) with at least one weight-related comorbidity.

Noninvasive liver exam plays role in fighting viral hepatitis and fatty liver disease

The FibroScan device pictured here assesses liver stiffness using Echosens patented VCTE technology.

Millions of Americans who are living with hepatitis C virus (HCV) will develop a chronic infection that, if left untreated, can cause serious health problems, including liver disease, cirrhosis, liver failure and liver cancer. More than one-third of HCV-infected individuals progress to advanced fibrosis and cirrhosis, and among those with cirrhosis, about 3–5% per year develop decompensated cirrhosis or hepatocellular carcinoma (HCC).

Nearly one-third of Americans have asymptomatic liver disease, also known as fatty liver disease (FLD). Approximately 85 million Americans have nonalcoholic fatty liver disease (NAFLD). In addition, a total of 20% have its more severe form, nonalcoholic steatohepatitis (NASH).

Liver disease often leads to developing other issues, such as advanced fibrosis, increased risk…

Lilly’s tirzepatide bests semaglutide in type 2 diabetes trial

Eli Lilly (NYSE:LLY) has announced that its investigational drug tirzepatide led to more substantial blood glucose and body weight improvements in a Phase 3 trial than semaglutide, a diabetes drug from Novo Nordisk (NYSE:NVO) that recently scored FDA approval for weight loss in early June.

Lilly’s SURPASS-2 results published in The New England Journal of Medicine show tirzepatide achieved superior A1C and body weight reductions compared to injectable semaglutide in adults with type 2 diabetes.

A JAMA opinion article recently posited that semaglutide could lead to a ‘new dawn’ for obesity treatment.

The Lilly trial randomly assigned patients to receive tirzepatide at doses of 5 mg, 10 mg, or 15 mg or a 1-mg dose of semaglutide.

Semaglutide is a glucagon-like peptide 1 receptor agonist. Conversely, tirzepatide is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist.

In the 40-week SURPASS-2 trial, i…

FDA approves Novo Nordisk’s semaglutide for weight management

FDA has approved Wegovy, the weekly semaglutide treatment for obesity from Novo Nordisk (CPH:NOVO-B).

The agency approved the use of semaglutide for type 2 diabetes in 2017. FDA approved an oral formulation for diabetes in 2019.

Semaglutide is a glucagon-like peptide (GLP-1) receptor agonist (RA) that continues to find wider use.

In clinical trials, Novo Nordisk people led to an average weight loss of 15% to 18% of body weight over 68 weeks in patients with obesity without diabetes.

In a clinical trial published in JAMA and The New England Journal of Medicine, semaglutide tripled weight loss for participants who received lifestyle management coaching.

Novo Nordisk continues to research new potential uses of the drug. It has launched clinical trials to test its use for conditions ranging from atherosclerosis to Alzheimer’s and Parkinson’s disease. A posthoc analysis involving three cardiovascular clinical trials found that participants recei…

Why Lilly’s tirzepatide has blockbuster potential

Tirzepatide from Eli Lilly (NYSE:LLY) continues to show promise for diabetes, outperforming popular diabetes drugs in head-to-head clinical trials, according to GlobalData.

In the recent SURPASS-4 study, tirzepatide supported the reduction of hemoglobin A1C (HbA1c) in people with type 2 diabetes while also supporting weight loss. The study pitted tirzepatide against insulin glargine.

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

The experimental drug also bested the injectable anti-diabetes drug semaglutide in the SURPASS-2 trial. Semaglutide from Novo Nordisk (NYSE:NVO) is currently FDA indicated as a treatment for type 2 diabetes. Semaglutide also supported substantial weight loss in a recent clinical trial, potentially supporting its use as an obesity treatment. Semaglutide is also a GLP-1 receptor agonist.

Novo Nordisk to test oral semaglutide as an obesity therapy

Global pharma firm Novo Nordisk (NYSE:NVO) will launch a Phase 3a study to investigate the potential of oral Ozempic (semaglutide) to treat obesity.

The drug is currently indicated in a subcutaneous form in the U.S. for people with type 2 diabetes to improve glycemic control in conjunction with diet and exercise and to lower diabetics’ risk of major adverse cardiovascular events.

The most recent Phase 3a trial will test an oral 50-mg dose of the drug with roughly 1,000 volunteers who are obese or overweight with comorbidities.

The company anticipates that the 68-week study will kick off in the second half of 2021.

Recent clinical trial results indicate that subcutaneous semaglutide paired with behavioral therapy can support weight loss.

Novo Nordisk has also filed a new drug application with the FDA for a 2.4-mg dose of subcutaneous semaglutide for chronic weight management. The company is seeking a similar indication in the European m…

Semaglutide shows promise for weight loss maintenance

Signs are growing that the diabetes drug Ozempic (semaglutide) from Novo Nordisk can support weight loss in overweight and obese individuals.

A recent JAMA study involving overweight and obese individuals gave recipients a 2.4-mg subcutaneous dose of semaglutide once weekly for 20 weeks. After that period, investigators continued administering the drug to half of the participants while giving the placebo to the remainder for an additional 48 weeks.

The group that continued to receive semaglutide lost an average of 7.9% of their body weight from week 20 to week 68. By contrast, placebo recipients gained 6.9% of their body weight in the same time frame.

Complicating matters were gastrointestinal side effects, reported in 49.1% of participants who continued to receive subcutaneous semaglutide. A total of 26.1% of placebo recipients also reported gastrointestinal side effects.

The study authors conclude that semaglutide supports weight loss by improvi…

FDA sends Novo Nordisk refusal to file letter for weekly 2-mg semaglutide

Novo Nordisk announced that the FDA issued a refusal-to-file letter related to its application to expand the label for once-weekly subcutaneous Ozempic (semaglutide).

The company had sought to expand the label for a 2.0-mg dose of once-weekly semaglutide to treat type 2 diabetes. It filed the letter on Jan. 20, 2021.

The letter indicates that FDA has concluded additional information is needed to review an application.

FDA requested information related to the new proposed manufacturing site for the drug.

Novo Nordisk stated that it believes it has sufficient data to warrant the label expansion application.

The company plans to resubmit the application to FDA in the second quarter of 2021.

The current FDA labeling recommends patients begin taking 0.25 mg of semaglutide once weekly, increasing to 0.5 mg after four weeks. Patients who require additional glycemic control can have the dose to 1 mg once weekly after an additional four weeks…