Home » News » “Eli Lilly’s Tirzepatide Shows Promising Results for Obesity Treatment, Potential FDA Approval by End of 2023”

“Eli Lilly’s Tirzepatide Shows Promising Results for Obesity Treatment, Potential FDA Approval by End of 2023”

New hope in the fight against obesity. The American pharmaceutical group Eli Lilly published this Thursday the results of a new clinical trial confirming that its molecule tirzepatide, for the moment approved in the United States against diabetes only, helped in weight loss. These data pave the way for a possible future authorization of this drug by the American Medicines Agency (FDA) for obese people specifically.

The study was conducted on just over 900 overweight or obese participants with diabetes type 2 (the most common). The drug is taken once a week in the form of an injection. People who received the highest dosage lost an average of 15.6 kg (15.7% body mass reduction) over about a year and a half (72 weeks). Side effects were usually gastrointestinal problems (nausea, diarrhea, vomiting…).

A first clinical trial, the results of which were published in a scientific journal in June 2021 and which this time involved obese or overweight people but not suffering from diabetes, had demonstrated an even greater weight loss, order of 21%.

Regulatory action by the end of the year?

With these results, Eli Lilly expects to finalize its application for obese or overweight patients “in the coming weeks”, and “expects regulatory action as early as the end of 2023”.

Tirzepatide mimics a gastrointestinal hormone (GLP-1) that activates receptors in the brain that play a role in appetite regulation. It has already been marketed under the name Mounjaro for people with type 2 diabetes, since an FDA authorization in May 2022. But some American doctors are already prescribing it outside of its marketing authorization for people wishing to lose weight. weight, even if they don’t have diabetes.

In the United States, approximately 40% of adults suffer from obesity. Treatments using analogues of GLP-1 represent real hope for many specialists, because they lead to much greater weight loss than the drugs available until now.

A market estimated at $54 billion

This is a considerable commercial stake for pharmaceutical companies: according to Morgan Stanley, the world market for treatments against obesity could represent 54 billion dollars by 2030. The Novo Nordisk laboratory already markets in the United States a new treatment of this type, called Wegovy, and approved by the FDA against obesity since June 2021.

Its licensed counterpart for diabetes, called Ozempic and using the same molecule (semaglutide), has experienced periodic stock-outs recently, after it became all the rage on social media for its weight-loss properties.

Experts are concerned that people who are not clearly overweight are misusing it to lose a few pounds.

In the United States, there is also a problem of access to these very expensive new drugs (around $1,000 dollars per month), which are frequently not reimbursed by health insurance. They must be taken over the very long term, at the risk of regaining weight when treatment is stopped.

2023-04-27 18:25:00


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