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The FDA approved Novo Nordisk's injectable for adults with obesity or overweight, the agency announced Friday.

The GLP-1 receptor was approved for chronic weight management in adults with obesity (BMI of 30 or greater) or for adults with overweight (BMI 27 or greater) with at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol, used in conjunction with a reduced calorie diet and an exercise regimen.

The once-weekly, injectable medication is approved at a dose of 2.4 mg for this indication.

"Today's approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program," said John Sharretts, MD, of 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."

In December 2017, semaglutide was first approved in a 0.5 mg and 1 mg injectable dosing sold under the trade name Ozempic, which is indicated for type 2 diabetes and risk reduction of major cardiovascular events including heart attack, stroke, and death in adults with type 2 diabetes with known heart disease. And in September 2019, an oral form of semaglutide was approved in 7 and 14 mg tablets, sold under the trade name Rybelsus, likewise indicated for type 2 diabetes.

Novo Nordisk's other GLP-1 receptor agonist agent, liraglutide -- sold under the trade name Victoza (1.2 or 1.8 mg/day) for type 2 diabetes -- was also approved under the name Saxenda (3 mg/day) for chronic weight management in adults with a BMI of 30 or over, or with a BMI of 27 or more and at least one weight-related medical condition in 2014.

The approval comes based off the Semaglutide Treatment Effect in People with Obesity (STEP) clinical program. The first trial of the program included nearly 2,000 adults with obesity or overweight with at least one weight-related comorbidity without diabetes at baseline. After 68 weeks of treatment those on semaglutide plus lifestyle intervention lost an average 14.9% of baseline body weight versus 2.4% for those on placebo (treatment difference -12.4%, 95% CI -13.4 to -11.5, P<0.001).

Almost 70% of those on semaglutide plus lifestyle intervention achieved a 10% or more weight loss, and more than half were able to lose 15% of their baseline body weight.

In the second installment of the clinical program, the drug plus lifestyle intervention also proved effective for weight loss in patients with overweight and type 2 diabetes.

"Semaglutide is by far the most effective drug intervention we have seen for weight management," lead trial investigator Robert Kushner, MD, of Northwestern University Feinberg School of Medicine in Chicago, previously told MedPage Today.

Wegovy will have a boxed warning on the potential risk of thyroid C-cell tumors -- as do all agents in the GLP-1 receptor agonist class. The drug should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called multiple endocrine neoplasia syndrome type 2 (MEN 2).

The drug should not be used with other GLP-1 receptor agonists, other semaglutide-containing products or other weight loss products, such as prescription or over-the-counter drugs or herbal products. Wegovy has also not been studied in patients with a history of pancreatitis, the FDA said.

The most common side effects seen with Wegovy during the clinical trials included gastrointestinal events -- commonly seen with this agent class -- and included nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease.

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