The U.S. Food and Drug Administration (FDA) has granted approval for Eli Lilly & Co.’s obesity drug Zepbound, marking a significant milestone in the battle against obesity. Clinical trials have shown that this drug can help patients lose an average of up to 48 pounds.
Addressing an Unmet Medical Need
Zepbound has been specifically approved for adults who are obese or overweight and who have at least one weight-related condition, such as high blood pressure or high cholesterol. This approval comes at a time when obesity and overweight rates in the United States are on the rise.
According to Dr. John Sharretts, director of the FDA’s Division of Diabetes, Lipid Disorders, and Obesity, “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.” It is estimated that about 70% of adults in the U.S. fall into the category of obesity or overweight, with many of them also having weight-related conditions.
The Science behind Zepbound
Tirzepatide, the active ingredient in Zepbound, is not new to the market. It is already approved under the brand name Mounjaro for the treatment of Type 2 diabetes. However, this new approval expands its potential impact on addressing obesity.
Zepbound is administered through a once-weekly injection, similar to Novo Nordisk’s Wegovy. During clinical trials, it was found that approximately one-third of patients who took the highest dose of Zepbound lost over 58 pounds. The starting weight for these patients was around 231 pounds, highlighting the drug’s efficacy.
Unique Mechanism of Action
What sets Zepbound apart from other obesity drugs on the market is its ability to activate both GIP and GLP-1 hormone receptors. Drugs like Wegovy and Ozempic primarily focus on the GLP-1 hormone. This dual mechanism of action makes Zepbound a promising option for individuals struggling with obesity and its associated health conditions.
In summary, the FDA’s approval of Zepbound offers new hope for individuals with obesity or overweight and related health issues. With its impressive weight loss results and unique mode of action, Zepbound has the potential to make a significant impact in the ongoing fight against obesity.
New Generation of Obesity Drugs Gain Approval Amid Growing Evidence
The approval of Zepbound, a new generation obesity drug, comes at a time when mounting evidence suggests that these drugs can also reduce cardiovascular risks. Dr. Daniel Skovronsky, chief scientific and medical officer at Eli Lilly, expressed his optimism about the approval, stating that it has the potential to contribute to both better health and lower costs for patients.
Clinical trials of Zepbound demonstrated that individuals who combined the drug with diet and exercise experienced reductions in blood pressure, although the drug itself is not approved for treating this condition.
To make Zepbound more accessible, Lilly will be launching a savings-card program. This program will allow people with commercial insurance to obtain the drug for as little as $25 for a one-month prescription. Additionally, individuals with commercial insurance that does not cover Zepbound may be eligible for a significant discount of approximately 50% off the list price.
Like any medication, Zepbound does have potential side effects, which include nausea, diarrhea, vomiting, and constipation, according to Lilly.
Dr. Leonard Glass, senior vice president of global medical affairs for Lilly Diabetes and Obesity, highlighted the challenges faced by many individuals when attempting to lose weight solely through diet and exercise. He explained that calorie restriction alone can actually make weight loss more difficult. With Zepbound, Lilly aims to dispel misconceptions about obesity and revolutionize how it can be effectively managed.
In response to this news, the shares of Lilly saw a 2% increase on Wednesday afternoon. Overall, the company’s shares have gained an impressive 67% year-to-date, surpassing the performance of the S&P 500 which has increased by 13.9% over the same period.