FDA Approves Widespread Diabetes Remedy for Use as Weight Loss Drug

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Share on PinterestWegovy is a synthetic version of an intestinal hormone that suppresses hunger and appetite and is the first drug the FDA approved for weight loss in 2014. Getty Images

  • The FDA has approved Wegovy, a higher dose of the diabetes drug semaglutide, as a weight loss drug in obese patients.
  • In clinical trials, non-diabetic participants who took Wegovy lost an average of 12.4 percent of their original body weight.
  • The drug is a synthetic version of an intestinal hormone that suppresses hunger and appetite.

A diabetes drug has received approval from the Food and Drug Administration (FDA) to also be used as a weight loss drug in obese patients.

The Wegovy drug is a higher dose of the diabetes drug Semaglutide manufactured by Novo Nordisk.

It is the first chronic weight loss drug to be approved by the FDA since 2014.

Wegovy is given by injection once a week and is indicated for people with a body mass index (BMI) of 27 kg / m2 or greater and at least one weight-related condition such as high blood pressure or high cholesterol. The drug is also suitable for people with a BMI of 30 kg / m2 or higher.

In the United States, about one in three adults – over 100 million people – are obese. Treating obesity can improve blood pressure, sugar, and cholesterol levels.

“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” Dr. John Sharretts, assistant director of the division on diabetes, lipid disorders, and obesity at the FDA’s Center for Drug Evaluation and Research, said in a statement.

Wegovy is a synthetic version of a hormone found in the gut, glucagon-like peptide-1, that affects the parts of the brain that control hunger and appetite.

It is injected under the skin once a week.

“It slows down the emptying of the stomach. It promotes satiety by acting on the brain, especially at the hypothalamus level, ”said Dr. Aleem Kanji, an endocrinologist and obesity medicine specialist at Ethos Endocrinology in Houston.

In clinical trials evaluating the safety and effectiveness of Wegovy for weight loss, non-diabetic participants who took Wegovy lost an average of 12.4 percent of their original body weight compared to those who received a placebo.

In a clinical study done in people with type 2 diabetes, those who took Wegovy lost 6.2 percent of their body weight compared to those who received a placebo.

Those who took Wegovy continuously lost weight for 16 months before reaching a plateau.

Gastrointestinal problems – diarrhea, vomiting, constipation, abdominal pain, indigestion, gas – have been commonly reported as side effects. These side effects usually went away on their own, but 5 percent of participants stopped taking the drug because of it.

Other participants reported headache, fatigue, and dizziness.

“People with obesity and type 2 diabetes are likely good candidates for the dual benefit of improved blood sugar control and weight loss,” Kanji said.

According to Kanji, the data suggests Wegovy has a favorable safety profile when compared to older weight loss drugs.

Wegovy should not be used with other weight loss drugs or drugs that contain semaglutide, according to the FDA.

Wegovy has a potential risk of developing thyroid C-cell cancer and should not be given to people with a personal or family history of medullary thyroid cancer and multiple endocrine neoplasia syndrome type 2 (MEN 2).

The drug has not been studied in patients with a history of pancreatitis.

The drug at a dose of 1 mg was first approved for type 2 diabetes in 2017.

Kanji plans to add Wegovy as a treatment option for certain obese patients – particularly those with type 2 diabetes.

The price is expected to be similar to Saxenda, which costs $ 1,349 per month without insurance.

“As is often the case, cost and health insurance coverage will be the limiting factor,” Kanji said.

The Food and Drug Administration has approved the diabetes drug semaglutide as a weight loss drug in obese patients. The drug is a synthetic version of an intestinal hormone that suppresses hunger and appetite. In clinical trials, participants who took the drug lost about 12 percent of their body weight compared to those who took a placebo. This is the first drug the FDA approved for weight loss since 2014.