Lilly’s tirzepatide wins FDA approval for type 2 diabetes

FDA has approved Mounjaro (tirzepatide), the first glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) for treating adults with type 2 diabetes.

Developed by Eli and Co., tirzepatide could quickly become a mega-blockbuster. According to Mizuho Securities, annual sales of the drug could approach $14 billion by 2030.

To win approval, Lilly provided data from the Phase 3 SURPASS clinical studies showing that it supported superior A1C reductions than all comparators, including insulin glargine and insulin degludec. The SURPASS trials also pitted tirzepatide against metformin, SGLT2 inhibitors and sulfonylureas.

The drug also has the side benefit of supporting weight loss, although it is not indicated for obesity. Volunteers in the SURPASS trials lost an average of 12 and 25 lb., depending on dose level.

In the SURMOUNT-1 study, the drug yielded up to 22.5% in adults with obesity or overweight.

Lilly will marke…

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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

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Regeneron uncovers genetic mutations that guard against obesity

Regeneron Pharmaceuticals (NSDQ:REGN) has announced that its Regeneron Genetics Center (RGC) has discovered rare genetic mutations associated with protection against obesity.

RGC researchers learned that people with at least one inactive copy of the GPR75 gene tend to weigh about 12 pounds less than those without that mutation. In addition, those individuals faced a 54% reduced risk of obesity.

The center made the finding after sequencing 640,00 exomes, which are part of the genome composed of exons.

A study published in Science that summarized the findings concluded that inhibiting “GPR75 may be a therapeutic strategy for obesity.”

Regeneron is working with partners such as Alnylam Pharmaceuticals to develop drug candidates that mimic the genetically afforded protection.

The mutations were only present in roughly one out of every 3,000 people. Some 645,000 volunteers from the U.K., U.S. and Mexico, participated in the study.

Regener…

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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…

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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…

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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.  

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