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FDA approves new weight loss drug from the makers of Mounjaro

The active ingredient in the new drug was already approved by the FDA for Eli Lilly's Mounjaro injections prescribed to treat Type 2 diabetes.
Posted at 1:19 PM, Nov 08, 2023

The U.S. Food and Drug Administration approved Zepbound, a new weight loss drug from pharmaceutical company Eli Lilly, on Wednesday. 

Zepbound is a once-weekly injectable medication with an active ingredient called tirzepatide. The ingredient is something the FDA previously approved for Eli Lilly’s Mounjaro injections, which are prescribed to treat patients with Type 2 diabetes. 

“This is just another tool for you to use and consider, it doesn’t mean it’s the right one and it doesn't mean you're a failure if it doesn't give you what you need,” said Dr. Michael A. Snyder, a bariatric surgeon and medical director of the Bariatric Surgery Center at Rose Medical Center.

The drug is similar as Novo Nordisk’s semaglutide injections known as Ozempic, also prescribed for diabetes but not approved for weight loss, and Wegovy, approved for weight loss treatment. 

@scrippsnews The FDA has approved a new drug for weight loss. #Zepbound, a drug previously approved under the name Mounjaro to help with diabetes, will be available by the end of the year. #weightloss ♬ original sound - Scripps News

“This is a medication that tries to mimic two gut hormones, whereas Ozempic and Wegovy, which are the same medication with the generic name of semaglutide, they mimic one of those two hormones called GLP-1,” said Dr. Scott Butsch, the director of obesity medicine in the Bariatric and Metabolic Institute at Cleveland Clinic.

In clinical trials, Zepbound was found to reduce body weight by 18% over 72 weeks of treatment in adults without diabetes when combined with a reduced-calorie diet and exercise, the FDA said. For adults with diabetes, body weight was reduced by 12%.

Zepbound is part of a class of drugs called GLP-1 agonists, which activate hormone receptors to reduce appetite and food intake. According to the FDA, Zepbound also mimics a glucose-dependent insulinotropic polypeptide (GIP) which helps to stimulate insulin secretion in response to food.

The medication is designed to increase dosage over a period of time with a maximum dosage of 15 milligrams, according to the FDA.

“These drugs are super powerful. They’re also super expensive and they’re also for life. So I'm not against them but you have to realize this is an investment in your health,” Dr. Snyder said.

Like other drugs in its class, Zepbound has the possibility of side effects like stomach discomfort, constipation, hair loss and other gastrointestinal issues.

Eli Lilly, which manufactures Zepbound, said the drug will be available by the end of the year at a price of $1,059 per month without insurance.

The FDA said approximately 70% of Americans are overweight and many have a weight-related condition as a result. The government agency has only approved a handful of medications to be used for weight loss, including Contrave, Saxenda, Alli, Qsymia and Imcivree.

“This is a new generation of promising drugs with clinical, meaningful weight loss, which is really merely a sign of what is to come,” Dr. Butsch said.

New weight loss drug on fast-track to rival Ozempic, Wegovy
The Eli Lilly & Co. corporate headquarters.

New weight loss drug on fast-track to rival Ozempic, Wegovy

Drugmaker Eli Lilly said it's seeking FDA approval of its drug Mounjaro to treat weight loss after late-stage trials showed unprecedented results.

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