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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…

Semaglutide paired with behavioral therapy tripled weight loss in trial

The diabetes drug Ozempic (semaglutide) could potentially enhance weight loss in overweight and obese patients without diabetes, according to a study recently published in JAMA and The New England Journal of Medicine.

In December, Novo Nordisk (NYSE:NVO) submitted a new drug application to the FDA for a 2.4-mg dose of subcutaneous semaglutide for chronic weight management.

The drug won FDA approval to manage type 2 diabetes in 2017

The 68-week randomized Phase 3a study involved 611 patients. At the end of the period, patients given weekly semaglutide lost 16% of their body weight while the placebo group lost 5.7%.

Participants in the trial received physical activity counseling. At the beginning of the trial, they received an eight-week meal replacement diet of 1000 to 1200 calories per day.

Some 3.4% of semaglutide recipients had gastrointestinal adverse events, and treatment for them was discontinued.

The study was conducted from Au…