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,”…
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…
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…
Noninvasive liver exam plays role in fighting viral hepatitis and fatty liver disease
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…
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…
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…
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…
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’…
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…
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…
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…