New Diet Drug Just Approved – The FDA approved an obesity drug that helped some people lose weight by 15%. In a comparison group that received sham vaccines, the average loss was less than 6 pounds.
This image provided by Novo Nordisk shows a package of the company’s semaglutide drug, called Wegovy. On Friday, the FDA said this new version of a popular diabetes drug could be sold as a weight-loss drug. Cristian Mihaila/AP hide caption
New Diet Drug Just Approved
This image provided by Novo Nordisk shows a package of the company’s semaglutide drug, called Wegovy. On Friday, the FDA said this new version of a popular diabetes drug could be sold as a weight-loss drug.
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Regulators said Friday that a new version of a popular diabetes drug could be sold as a weight-loss drug in the US.
The Food and Drug Administration has approved Wegovy, a higher-dose version of Novo Nordisk’s diabetes drug semaglutide, for long-term weight management.
In studies funded by the company, participants who took Wegovy had an average weight loss of 15%, about 34 pounds (15.3 kg). The participants lost weight steadily for 16 months before they sat down. In a comparison group that received sham shots, the average weight loss was about 2.5%, or just under 6 pounds.
“With existing drugs, you’ll get maybe a 5% to 10% weight loss, sometimes not even that much,” said Dr. Harold Bays, medical director of the Metabolism and Atherosclerosis Research Center in Louisville. Bays, who is also the director of science for the Society of Obesity Medicine, helped conduct the drug studies.
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Losing as much as 5% of weight can have health benefits such as improving energy, blood pressure, blood sugar and cholesterol levels, but that amount often doesn’t satisfy patients who are focused on weight loss, Bays said.
Bays said Wegovy appears much safer than previous obesity drugs that have “come under fire” for safety concerns. The most common side effects of Wegovy were gastrointestinal problems, including nausea, diarrhea and vomiting. These generally decreased, but it took about 5% of study participants to stop taking it.
The drug carries a potential risk for a type of thyroid tumor, so it should not be taken by people with a personal or family history of certain thyroid and endocrine tumors. Wegovy is also at risk for depression and inflammation of the pancreas.
Wegovy (pronounced wee-GOH’-vee) is a synthesized version of a gut hormone that suppresses appetite. Patients inject weekly under the skin. Like other weight loss medications, it should be used in conjunction with exercise, a healthy diet, and other steps such as keeping a food diary.
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The Danish company did not disclose the price of Wegovy, but said it will be similar to the price of Saxenda, an 11-year-old injectable weight-loss drug that now typically costs more than $1,300 a month without insurance.
Dr. Archana Sudhu, head of the diabetes program at Houston Methodist Hospital, said Wegovy’s usefulness “is all about the price.” She noted that patients’ health plans sometimes don’t cover weight loss treatments, leaving expensive medications out of reach.
Sudhu, which has no ties to Novo Nordisk, plans to switch obese patients with type 2 diabetes to Wegovy. This makes patients feel full more quickly and increases the release of insulin from the pancreas to control blood sugar, she said. Patients would then be more likely to be motivated to exercise and eat healthier, she added.
Wegovy builds on a trend in which relatively new makers of diabetes drugs are testing them to treat other conditions common in diabetics. For example, Novo Nordisk’s popular diabetes drugs Jardiance and Victoza now have approvals to reduce the risk of heart attack, stroke and death in heart patients.
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Phylander Pannell, 49, of Largo, Maryland, participated in a study of patients after cycles of weight loss and weight regain. She said she took Wegovy, worked out several times a week and lost 65 pounds in 16 months.
“It helped reduce my appetite and helped me feel full faster,” Pannell said. “Put me on the right path.”
Shortly after she finished the study and stopped taking Wegovy, she regained about half her weight. Since then, she has missed a lot, started gym classes and bought home gym equipment. She is considering returning to Wegovy once she is approved. It is the fourth drug approved in the country to help people with chronic weight problems.
Melbourne physiologist Professor Michael Cowley developed the drug while working abroad, after mapping key brain areas involved in regulating food intake.
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The two ingredients naltrexone and bupropion are currently used separately in medications to overcome substance abuse and help stop smoking.
“We found that there were two places where these two drugs could interact and produce an effect on appetite, to decrease appetite, but also an effect on something called the reward center to reduce what appeared to be the desire for food,” he said.
Contrave’s effects on weight loss, along with a low-calorie diet and increased physical activity, have been the subject of several trials.
In one study, weight loss of at least 5% of baseline body weight was observed more often among patients treated with Contrave compared to placebo.
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“Losing five per cent weight will not cause a dramatic change in people’s appearance, but it does improve metabolic health,” Professor Cowley said.
He said this includes lowering the risk of heart attack and lowering the risk of diabetes and cholesterol conditions.
Common side effects seen in the trials were nausea, vomiting and constipation, and there is a rare risk of seizures and suicidal thoughts.
People taking the medication are asked to stop after 16 weeks if they have not lost at least 5% of their initial body weight.
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Obesity expert Professor John Dixon says the addition of Contrave gives doctors another chance to treat more people correctly.
He says the 1.5 million Australians who are morbidly obese are not being treated effectively and are often blamed on a lack of willpower.
Contrave should only be taken for a maximum period of 16 weeks as it has some side effects. ( )
“The drugs would have to be taken continuously and I don’t think, really, we know enough about the long-term use of these drugs,” said Professor Gary Wittert, Director of Medicine at the University of Adelaide. .
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“For specific circumstances where extra help is needed, medication may find a place. But, to be honest, we don’t know enough about who will benefit most and under what circumstances,” Professor Wittert said.
In Australia, Contrave is intended for adults who are obese or have metabolic problems caused by obesity. There is no magic pill that will cure obesity, a condition that affects more than 40% of adults in the United States. But there are new types of drugs that could change the game. They’re anti-obesity drugs, and doctors say part of what makes them unique is the way they’re prescribed: They’re used to treat obesity for the chronic metabolic disease it is, rather than perpetuate the misconception that obesity is a problem. that can be overcome. by will.
One such drug that has made headlines is tirzepatide. According to a study published in June in
, use of the drug, a new GIP/GLP-1 receptor agonist, in the study resulted in more than 20% weight loss in those with obesity—an average of 52 pounds per person.
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“These results are an important step toward potentially expanding effective therapeutic options for individuals with obesity,” says Ania Jastreboff, MD, PhD, a pediatric and adult endocrinologist at Yale Medicine and a nationally recognized expert in obesity medicine. .
Tirzepatide has not yet been approved by the Food and Drug Administration (FDA) for use as an anti-obesity medication. However, it is approved for the treatment of type 2 diabetes. The drug’s trial sponsor, Eli Lilly, is working with the FDA on a timeline for approval.
), and is given once a week by self-injection under the skin. It was approved by the FDA for the treatment of overweight and obesity in June 2021 (with similar drugs also in development). Semaglutide does not work for everyone, but when it is successful, it can help someone lose 15% of their body weight. (If you weigh 200 pounds, for example, that would be 30 pounds.)
“This medication helps you feel full faster,” says Dr. Jastreboff. “That means you’ll have little desire to reach for seconds or a snack later.”
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Anti-obesity drugs have been around for decades and there are several of them currently in use. But semaglutide is the first of a new generation of highly effective hormone-based obesity drugs. Semaglutide mimics a hormone called glucagon-like peptide-1 (GLP-1), which is secreted in the gut and targets receptors throughout the body, including the brain. When a person is eating, GLP-1 sends the “I’m full” signal to the brain, says Dr. Jastreboff.
Semaglutide also reduces “gastric emptying,” the process by which stomach contents move into the first part of the small intestine as part of the digestive process. “But this effect diminishes over time,” says Dr. Jastreboff. “The main way semaglutide helps treat obesity is through its action on the brain.”
However, the drug – and the drug class – is not new; this class of
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