① The US FDA announced on its official website that it has approved Lilly's Tirzepatide injection for long-term weight management, and the product name is “Zepbound”; ② The FDA's approval of Zepbound has helped Lilly establish a competitive position with Novo Nordisk in the field of weight loss drugs.
On Wednesday (November 8) local time, the US Food and Drug Administration (FDA) announced its approval on its official website$Eli Lilly and Co (LLY.US)$Tirzepatide injections are used for long-term weight management, and the trade name is “Zepbound.”
According to information, Tirzepatide is a glucose-dependent insulinizing polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist developed by Lilly. It can bind and activate the human natural intestinal insulinizing receptor GIP receptor and GLP-1 receptor. Simply put, after taking it, it can reduce the patient's appetite and food intake.
In May of last year, the FDA approved the drug to improve blood sugar control in adults with type 2 diabetes. The trade name is “Mounjaro.” Today, the regulator has expanded its scope of application, and two categories of adults can use the drug on the basis of diet control and exercise:
In the first category, adults with obesity (BMI greater than or equal to 30), BMI is calculated by dividing body weight (kg) by height (m) squared;
The second category, adults who are overweight (BMI greater than or equal to 27) and suffer from at least one weight-related disease, such as high blood pressure, type 2 diabetes, high cholesterol, etc.
As evidence for this approval, the detailed results of the phase III clinical study SURMOUNT-2 showed that the average body weight of the subjects with Tirzepatide 10 mg and 15 mg decreased by 13.4% (13.5 kg) and 15.7% (15.6 kg), respectively, while the placebo group participants lost 3.3% (3.2 kg) in weight.
JohnSharretts, Director of Diabetes, Lipid Disorders, and Obesity at the FDA Center for Drug Evaluation and Research, wrote, “Obesity and overweight are worrying health conditions that can lead to serious diseases such as heart disease, stroke, and diabetes. In light of rising obesity and overweight rates in the US, today's approval addresses unmet health care needs.”
From 2017 to March 2020, the obesity rate in the US was 41.9%, according to the US Centers for Disease Control and Prevention. In comparison, the figure from 1999 to 2000 was only 30.5%, an increase of more than 10 percentage points. Furthermore, the prevalence of severe obesity has almost doubled from 4.7% to 9.2%.
Last month, Goldman Sachs analysts believed that by 2030, the weight loss drug market would develop into an industry worth 100 billion US dollars. This means that the FDA's approval of Zepbound has helped Lilly establish a competitive position with Novo Nordisk.
Eli Lilly's press release finally mentioned that Zepbound is expected to be marketed in the US by the end of this year. There are 6 doses, and the list price is 1,059.87 US dollars, compared to$Novo-Nordisk A/S (NVO.US)$The price of Wegovy is about 20% lower. Some media mentioned that due to Wegovy's supply restrictions, some Americans had previously used Tirzepatide for weight loss.
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