The FDA has given approval for a new iteration of a medication used to treat diabetes, which also aids in weight loss.
On Wednesday, U.S. regulators announced that a new edition of the well-known diabetes medication Mounjaro can now be marketed as a weight-loss medication.
The recent study showed that the U.S. Food and Drug Administration has given its approval for Eli Lilly’s Zepbound, also known as tirzepatide. This drug has been found to assist in weight loss, with dieters losing an average of 27 kilograms, which is equivalent to about a quarter of their body weight.
Zepbound is the newest medication for diabetes that has been authorized for promoting weight loss. It is now available alongside Novo Nordisk’s Wegovy, which is a high-dose variation of their diabetes medication, Ozempic.
The FDA has given its approval for Lilly’s medication to be used by individuals who are classified as obese, with a body mass index of 30 or above, or those who are overweight with a medical issue such as high blood pressure, high cholesterol, or diabetes. According to the FDA, the medication should be combined with a nutritious diet and consistent physical activity.
In America, approximately 100 million adults and 15 million children are classified as obese.
Tirzepatide, found in Zepbound and Mounjaro, and semaglutide, found in Wegovy and Ozempic, function by replicating hormones that naturally occur after eating to control hunger and satiety. These medications mimic the effects of a hormone known as GLP-1 (glucagon-like peptide-1). Additionally, Tirzepatide also targets another hormone called GIP (glucose-dependent insulinotropic polypeptide).
Zepbound appears to spur greater weight loss than Wegovy. Approved for chronic weight management in 2021, Wegovy helped people lose about 15% of their body weight or 15.4 kilograms, according to study results.
Dr. Fatima Cody Stanford, an expert in obesity medicine at Massachusetts General Hospital in Boston, stated that this drug would be the most effective treatment for obesity ever approved.
Promoted by famous individuals and on online platforms, semaglutide and tirzepatide have been in high demand, causing difficulties for their producers to meet the demand. Both have been included on the FDA’s list of drugs in short supply for several months. Currently, all dosages of tirzepatide are reported as being in stock, but a representative from the company stated that availability may differ based on location and demand.
Adverse reactions associated with the novel weight-loss medication may include vomiting, nausea, diarrhea, constipation, and other gastrointestinal issues. The most recent trial showed that approximately 10% of individuals using tirzepatide discontinued the study due to these concerns, in contrast to only 2% of those receiving placebo injections.
Although praised for its approval, experts expressed concern that this may not result in increased availability of Zepbound, a drug that has been used off-label to aid weight loss.
Dr. Katherine Saunders, a specialist in obesity at Weill Cornell Medicine in New York and co-founder of a company that specializes in treating obesity, stated that the majority of patients will not have the means to pay for Zepbound unless they have insurance coverage. Additionally, numerous health plans do not cover obesity care.
Eli Lilly and Co. announced that the monthly cost will be approximately $1,000, which is equivalent to Mounjaro. Medicare is not allowed to provide coverage for medications intended solely for weight loss.
Kelly Burns, a 50-year-old resident of St. Petersburg, Florida, achieved a weight loss of almost 45 kilograms by taking tirzepatide as part of a 2021 study on treating obesity. After the study concluded and she was no longer able to use the drug, she faced challenges but ultimately managed to lose an additional 23 kilograms.
She stated that her entire life has changed drastically. Her health has gotten better and she feels more confident. She is now considering inquiring with her insurance provider about coverage since it is authorized for weight loss.
She stated that it would be absurd not to, and expressed her desire to maintain this state for as long as possible.