Obesity treatment drug ``Zepbound'' that can reduce patient weight by up to 25% receives approval from the US Food and Drug Administration

On November 8, 2023, the US Food and Drug Administration (FDA) announced that it has approved the sale of Zepbound, an obesity treatment drug developed by the American pharmaceutical company

Eli Lilly .

FDA Approves New Medication for Chronic Weight Management | FDA

FDA Approves Lilly's Zepbound™ (tirzepatide) for Chronic Weight Management, a Powerful New Option for the Treatment of Obesity or Overweight with Weight-Related Medical Problems | Eli Lilly and Company


Lilly weight-loss drug Zepbound gets US, UK approval to rival Wegovy | Reuters

Eli Lilly's obesity treatment drug Zepbound uses receptors for two hormones secreted from the intestines: glucagon-like peptide-1 (GLP-1) and glucose-dependent insulin secretagogue polypeptide (GIP). is a drug that reduces appetite and food intake in patients who receive it. On November 8, 2023, the FDA announced that adults with a body mass index (BMI) greater than 30 kg/m² who are considered obese, or adults with a BMI greater than 27 kg/m² who are considered 'overweight' Zepbound has been approved for administration by injection for weight management.

Patients determined to be obese or overweight are given 5 to 15 mg of Zepbound by injection once a week for 4 to 20 weeks. In addition, while administering Zepbound, patients are required to eat a low-calorie diet and increase physical activity.

The effectiveness of Zepbound was confirmed by a randomized, double-blind, placebo study conducted by a research team. These studies compared weight trends after 72 weeks in a total of 2,519 patients who received 5 mg, 10 mg, or 15 mg of Zepbound once a week and 958 patients who also received a placebo. At all three dose levels, patients receiving Zepbound reported significantly lower body weight compared to patients receiving placebo. According to Eli Lilly, one in three patients who took Zepbound at the highest dose successfully lost 25% or more of their body weight.

In addition, since obesity is also related to

type 2 diabetes , the research team conducted a placebo trial with and without diabetes. Studies have shown that when Zepbound or a placebo was administered to adults without diabetes, patients receiving Zepbound lost an average of 18% of their weight compared to the placebo group. Similarly, in a study conducted in adults with diabetes, patients receiving Zepbound lost an average of 12% in weight compared to the placebo group.

'Obesity and overweight are some of the leading causes of death in Americans, including heart disease, stroke, and diabetes,' said John Sharetz, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research. This is a serious physical condition that can lead to obesity. With approximately 70% of American adults considered obese or overweight, the approval of Zepbound is an important step in the medical field's efforts to address obesity. It's a response to a need.'

According to the FDA, losing 5% to 10% of body weight through proper diet and exercise can reduce the risk of cardiovascular disease in patients who are determined to be obese or overweight. thing.

On the other hand, the FDA reported that Zepbound has side effects such as nausea, diarrhea, vomiting, constipation, and stomach discomfort and pain, and that tumors developed in thyroid C cells in experiments on rats. Therefore, it is cautioned that Zepbound should not be administered to patients with a history of thyroid cancer or to patients who have an allergic reaction to tirzepatide , the active ingredient in Zepbound.

Eli Lilly plans to start selling Zepbound at pharmacies from the end of November, and has announced that it will approximately double its manufacturing capacity by the end of 2023. In addition, Eli Lilly reports that Zepbound will be sold for $ 1059.87 per month (about 160,000 yen) and may be added to the scope of insurance coverage in 2024.

in Science, Posted by log1r_ut