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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.
New weight loss drug on fast-track to rival Ozempic, Wegovy
Posted at 12:57 PM, Apr 28, 2023

As more Americans turn to drugs like Ozempic and Wegovy to slim down, a new obesity medicine is showing even better results, and it could soon upend the market.

Eli Lilly's tirzepatide, which is marketed under the brand name Mounjaro to treat type 2 diabetes, has helped overweight people with the disease lose up to 34 pounds, the company said in a press release Thursday. In late-stage trials, diabetics who were overweight or obese saw their weight drop by up to 16% over 17 months.

Those without the disease saw even greater results taking Mounjaro, losing up to 22% of their body weight, the study showed. Additionally, nearly four-in-ten adults taking the highest dose of the drug lost 25% or more of their total body weight. For someone who's over 220 pounds, that could mean a loss of more than 50 pounds. 

Based on the new, unprecedented results, Eli Lilly announced plans to seek fast-track approval from the U.S. Food and Drug Administration to advertise and sell the drug for weight management. It could gain authorization by the end of this year.

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"Based on these results, Lilly plans to complete the U.S. submission for tirzepatide in adults with obesity or overweight with weight-related comorbidities in the coming weeks," the company said. "We expect regulatory action as early as late 2023." 

The injectable drug gained FDA approval as Mounjaro in May of last year to treat adults with type 2 diabetes, but thousands of patients have used it off-label to help them slim down.

"Mounjaro is the hot new medication that we're all really excited about in the medical world," said Jennah, a board certified MD who goes by the username @weightdoc on TikTok. "FDA approved for diabetes only right now, but it's already being used off-label for obesity."

Industry experts predict that it could become one of the best-selling drugs ever, outpacing similar drugs like Ozempic and Wegovy, both of which have gained widespread popularity after gaining FDA approval to manage weight.

Social media posts containing #Wegovy, #Ozempic and #Mounjaro have generated hundreds of millions of views and now more people are flocking to get their hands on this new generation of drugs to help them shed some pounds. But the popularity of the drugs has put them out of reach for some needy patients.

"Because of the unfortunate TikTok trend, we're running out of Ozempic for diabetics. For diabetics this is a life-saving medication, for heart attack and stroke," said Dr. Frank Chae, who works at Sky Ridge Medical Center.  

SEE MORE: The science and safety behind newly popular weight loss drugs

For patients, the new trend could mean an even more effective way of losing weight without invasive surgeries.

While these new medications can have side effects, they're considered much less severe than those of obesity drugs in the past. For Mounjaro, "the most common side effects reported by patients were nausea, diarrhea and decreased appetite."

Dr. Michelle Guy, director of the American Board of Obesity Medicine, says obesity, which already affects more than 41% of Americans, has been on the uptick in recent years.

"We are becoming a more obesogenic society," Guy said. "We have more access to calorie-dense foods, as well as sometimes our infrastructure doesn't support having more access to commuting, walking, having a more healthy lifestyle outdoors."

Eli Lilly has already boosted production of Mounjaro in anticipation of widespread demand should it gain FDA approval.


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