"Today's approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program," said John Sharretts, M.D., deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research in a statement. "FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight."
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The drug, semaglutide, known commercially as Wegovy, was previously approved for FDA use at a lower dose for Type 2 diabetes treatment. Samon Husma, of Wake Forest, has been taking it the past three months for that reason.
"The drug changed my perspective of looking at food. So by looking at food or smelling food, the foods I used to like, I did not like," said Husma, who added she initially was nauseous from the medication, which is a listed side effect.
Husma, who was diagnosed with diabetes in 2018, has lost 15 pounds in the past three years, and plans to continue taking the drug.
"I am happy with the weight loss, because I needed that. That will (help) control my diabetes also, but I will see how long term it will (last)," said Husma.
The drug was studied over four 68-week trials, three of which were randomized double-blind, placebo controlled trials, and a fourth which was a double-blind, placebo-controlled, randomized withdrawal trial.
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In a trial featuring adults without diabetes, on average participants lost 12.4% of their initial body weight. A separate trial included adults with Type 2 diabetes, where the average weight loss was 6.2%.
"It's a very effective drug, and we need more tools like this for treating obesity effectively. Most people when they think of obesity, they're thinking of surgery, or they're just thinking of lifestyle changes. And medications have not had the kind of effectiveness so far to make it a really good alternate to surgery," said Dr. Sriram Machineni, the Director of Medical Weight Clinic for UNC, who served as a trial investigator.
The CDC reports more than 42% of Americans are obese, a startling statistic highlighting the wide range of the issue.
"Whenever you have obesity, you have the other things that follow, which is high blood pressure, diabetes, you have sleep apnea. The cost of obesity to an economy, the country, and state are staggering," said Dr. Macineni.
"It's a worldwide issue, and North Carolina is one of the state's higher in obesity than some of (others)," said Dr. Will Yancy, the Director of the Duke University Lifestyle and Weight Management Center.
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Doctors stress the continued importance of lifestyle changes, including to diet, physical activity, and sleep, in conjunction with the medication.
"If we want to make an impact, then we want to use what's available to us. And medications are part of that. We'll probably use this readily once it becomes available and insurers are covering it," said Dr. Yancy.
Side effects include, but are not limited to, nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, dyspepsia (indigestion), dizziness, abdominal distension, eructation (belching), hypoglycemia (low blood sugar) in patients with type 2 diabetes, flatulence (gas buildup), gastroenteritis (an intestinal infection) and gastroesophageal reflux disease (a type of digestive disorder).
To read the full FDA release, including further side effect information, click here.