{"id":5831,"date":"2023-08-18T05:40:48","date_gmt":"2023-08-18T05:40:48","guid":{"rendered":"https:\/\/healthnewscentral.com\/?p=5831"},"modified":"2023-08-18T05:40:48","modified_gmt":"2023-08-18T05:40:48","slug":"mounjaro-medication-on-shortlist-for-fda-approval-as-potential-new-drug-for-obesity-and-overweight","status":"publish","type":"post","link":"https:\/\/healthnewscentral.com\/mounjaro-medication-on-shortlist-for-fda-approval-as-potential-new-drug-for-obesity-and-overweight\/","title":{"rendered":"Mounjaro Medication On Shortlist For FDA Approval As Potential New Drug For Obesity And Overweight"},"content":{"rendered":"
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Everyday Health<\/figcaption><\/figure>\n

Many people that struggle with obesity are constantly looking for ways to lose weight. Just recently, the diabetes<\/a> medication called Mounjaro (tirzepatide)<\/a>, which is approved by the U.S. Food and Drug Administration (FDA)<\/a>, is now edging closer to becoming an authorized treatment for adults dealing with obesity and being overweight.<\/p>\n

In a recent announcement dated April 27, 2023<\/a>, by Eli Lilly, the drug\u2019s manufacturer, it was revealed that Mounjaro demonstrated promising results in the SURMOUNT-2 trial \u2013 the second phase 3 clinical trial for chronic weight management. Over the course of 18 months, individuals with diabetes participating in the trial achieved a remarkable reduction of nearly 16 percent in their body weight, equivalent to an average weight loss of approximately 34 pounds.<\/p>\n

Jeff Emmick, MD, PhD, the senior vice president of product development at Lilly, said\u00a0in the statement<\/a>, “Obesity is a difficult-to-manage disease, and it’s even more difficult for people living with type 2 diabetes. The degree of mean weight reduction seen in SURMOUNT-2 has not been previously achieved in phase 3 trials for obesity or overweight and type 2 diabetes.”<\/strong><\/em><\/p>\n

\n

What Do We Know About Mounjaro?<\/strong><\/h3>\n

This trial focused specifically on adults dealing with type 2 diabetes accompanied by obesity or being overweight. Fatima Cody Stanford, MD, MPH<\/a>, an associated professor of medicine at Harvard Medical School and an obesity medicine physician scientist at Massachusetts General Hospital<\/a>, remarked that this study reinforces prior observations related to tirzepatide.<\/p>\n

\u201cThese findings aren\u2019t surprising, since we\u2019ve seen really great results with this drug in patients with type 2 diabetes,\u201d<\/strong><\/em> says Dr. Stanford.<\/p>\n

Mounjaro, a member of the glucagon-like peptide-1 (GLP-1) agonist class of medications, gained its initial FDA approval<\/a> in May 2022. This class also includes semaglutide (marketed as Ozempic<\/a>), and FDA-approved weight loss drug for type 2 diabetes (T2D).<\/p>\n

Both tirzepatide and semaglutide are administered through self-injection beneath the skin of the abdomen, thigh, or upper arm on a weekly basis.<\/p>\n

In the earlier phase 3 trial called SURMOUNT-1<\/a>, which investigated Mounjaro\u2019s efficacy and safety among individuals with overweight or obesity but without diabetes, substantial weight loss results were achieved. Participants in that trial experienced weight reductions of up to 22.5 percent of their initial body weight.<\/p>\n

The average total weight loss was higher in the earlier trial in people without T2D, which is to be expected, says Stanford.<\/p>\n

Dr. Standford explains that, as expected, the average total weight loss was higher in the earlier trial in those without T2D. She says, \u201cWe see this consistently. Although metabolic or\u00a0bariatric surgery<\/a>\u00a0and pharmacotherapy are effective in people with diabetes, they typically don\u2019t respond as well as people without diabetes.\u201d<\/strong><\/em><\/p>\n

\n

\u2018Game Changing\u2019 Weight Loss Results with Mounjaro<\/strong><\/h3>\n

The latest trial involved 938 adult participants struggling with obesity or being overweight with type 2 diabetes. In combination a reduced-calorie diet and increased physical activity, participants were administered either 10 milligrams (mg) or 15 mg of Mounjaro, compared to a placebo.<\/p>\n

Participants had a \u2018mean baseline body weight of 222 pounds (lb) and a baseline A1C<\/a> of 8.0 percent.\u2019<\/p>\n

On either dose, over 80 percent of participants managed to shed 5 percent or more of their body weight. The weight reduction percentages were 13.4 percent (29.8 pounds (lb) or 13.5 kilograms (kg) on 10 mg and 15.7 percent (34 lb or 15 kg) on 15 mg compared to placebo.<\/p>\n

Meanwhile, reductions in A1C as compared with the placebo were similar to what they found in the clinical trials done on the drug and type 2 diabetes treatment.<\/p>\n

\n

New Trial Results Solidify Efficacy of Tirzepatide for Obesity and Overweight<\/strong><\/h3>\n

However, it\u2019s essential to note that Mounjaro carries a cautionary note regarding the potential risk of thyroid C-cell tumors, based on findings in rat studies. While it\u2019s unknown whether this risk extends to humans, the medication is not recommended for individuals with a history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2.<\/p>\n

Section chief of minimally invasive and bariatric surgery at Stanford University in Palo Alto, California, Dan Azagury, MD<\/a>, he explained that the findings were similar to what was seen in earlier trials of the medication for those with T2D. Notably, Dr. Azagury was not involved in the study.<\/p>\n

\u201cThat had led to its FDA approval for use in diabetes. But the weight loss results were game changing in that trial already. This is a study for the FDA; it\u2019s necessary to get the indication for use to\u00a0treat obesity<\/a>. But [it\u2019s] nothing very new scientifically \u2014 more a confirmation of what we all knew,\u201d<\/strong><\/em> says Dr. Azagury.<\/p>\n

\n

Safety and Side Effects of Mounjaro<\/strong><\/h3>\n

Despite the encouraging results, the safety profile of tirzepatide remained consistent with earlier trials.<\/p>\n

Dr. Stanford shares, \u201cAs we would expect, GI issues are going to be the most common side effects. This is common among this category of medicines.\u201d<\/strong><\/em><\/p>\n

Common side effects such as gastrointestinal issues were reported, including nausea, diarrhea, vomiting, and constipation. These side effects were generally mild to moderate in severity and primarily occurred during the dose escalation phase.<\/p>\n

\u00a0\u201cThe discontinuation rates (how many people dropped out before the trial ended) are relatively low, especially in a trial like this in this population,\u201d<\/strong><\/em> she says.<\/p>\n

The drug also carries a warning risk for thyroid C-cell tumors, since Mounjaro causes thyroid C-cell tumors in rats. However, what\u2019 not known is whether the drug causes such tumors, including that of medullary thyroid cancer, in humans.<\/p>\n

As for the prescribing information, Mounjaro shouldn\u2019t be sued in those with personal or family history of medullary thyroid cancer, or in those with multiple endocrine neoplasia syndrome type 2<\/a>.<\/p>\n

\n

Will FDA Approval Provide Easy Access to Mounjaro?<\/strong><\/h3>\n

Dr. Azagury says that physicians already knew that the drug could be used off-label to treat obesity. \u201cThis new study opens the door to its approval by the FDA. In turn, it will hopefully lead to broader insurance reimbursement. That\u2019s the main barrier we face now: The drugs work; our patients need them. But they can\u2019t get access because the cost is prohibitive, and insurance won\u2019t cover it,\u201d<\/strong><\/em> he says.<\/p>\n

He also says that the sad reality is that it will impact patients that fall under a lower socioeconomic status, more than others at least, increasing health inequities. That\u2019s because they tend to get impacted by this disease more while being denied access to treatment too.<\/p>\n

The drug\u2019s list price<\/a> is approximately $1,023.04 per fill, equating to over $50,000 annually without insurance coverage.<\/p>\n

Dr. Stanford agrees that coverage is key. \u201cIf you can\u2019t get access to the medicine, it\u2019s like a shiny ornament on a shelf that you can\u2019t reach. That doesn\u2019t help me or my patients. If a lot of people can\u2019t get it \u2014 or if they get approved initially and then after three months they\u2019re rejected from approval \u2014 imagine how discouraging that is,\u201d<\/strong><\/em> she says.<\/p>\n

The weight loss that comes with Mounjaro and other drugs in this class can be life-changing, shares Dr. Stanford. \u201cThis isn\u2019t about how someone looks \u2014 it\u2019s improving their entire cardiometabolic health,\u201d<\/strong><\/em> she says.<\/p>\n

Just like with other chronic disease treatments, patients need to remain on Mounjaro throughout their lifetime to treat both diabetes and obesity or being overweight.<\/p>\n

\n

FDA Approval to Treat Obesity and Overweight Possible By End of 2023<\/strong><\/h3>\n

Eli Lilly plans to continue its \u201crolling\u201d submission of the drug for approval for individuals with obesity or overweight and weight-related comorbidities. This process, according to the agency<\/a>, is part of the \u201cfast track\u201d approval mechanism, which aims to expedite new drug availability to patients. It allows sections of the new drug application to be submitted to the FDA as they are completed.<\/p>\n

Just last December 2022, Mounjaro was included in the FDA\u2019s drug shortage list. If it gets approved for overweight and obesity, the demand will become even more.<\/p>\n

As per Reuters<\/a>, the company is optimistic about receiving FDA approval by late 2023 and intends to double its manufacturing capacity by the end of this year.<\/p>\n

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Many people that struggle with obesity are constantly looking for ways to lose weight. Just recently, the diabetes medication called Mounjaro (tirzepatide), which is approved by the U.S. Food and Drug Administration (FDA), is now edging closer to becoming an authorized treatment for adults dealing with obesity and being overweight. In a recent announcement dated […]<\/p>\n","protected":false},"author":9,"featured_media":5832,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"image","meta":[],"categories":[1],"tags":[],"yoast_head":"\nMounjaro Medication On Shortlist For FDA Approval As Potential New Drug For Obesity And Overweight<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/healthnewscentral.com\/mounjaro-medication-on-shortlist-for-fda-approval-as-potential-new-drug-for-obesity-and-overweight\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Mounjaro Medication On Shortlist For FDA Approval As Potential New Drug For Obesity And Overweight\" \/>\n<meta property=\"og:description\" content=\"Many people that struggle with obesity are constantly looking for ways to lose weight. 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