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Tirzepatide: New Weight Loss Drug May Soon Receive FDA Approval for Obese Patients

These results pave the way for a possible future authorization of this drug by the American Medicines Agency (FDA) specifically for obese people.

The study was conducted on just over 900 participants who were overweight or obese and had type 2 diabetes (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 pounds (15.7% body mass reduction) over about a year and a half (72 weeks).

Side effects were usually gastrointestinal problems (nausea, diarrhea, vomiting…). With these results, Eli Lilly plans to finalize its application for obese or overweight patients “in the coming weeks”, and “expects regulatory action as early as the end of 2023”.

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, 21% order.

Tirzepatide mimics a gastrointestinal hormone (GLP-1) that activates receptors in the brain that play a role in appetite regulation. It is already marketed under the name Mounjaro for people with type 2 diabetes, since FDA clearance in May 2022.

But some American doctors already prescribe it outside of its marketing authorization for people wishing to lose weight, even if they do not have diabetes.

Experts worry about misuse

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.

This is a huge business issue 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 is already marketing a new treatment of this type in the United States, called Wegovy, and authorized 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.

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2023-04-27 16:21:07
#Health #American #pharmaceutical #group #developing #treatment #obesity

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