FDA clears first chronic weight loss drug in 7 years

Semaglutide injection (Wegovy, Novo Nordisk), a 2.4 mg once-weekly injection, is for chronic weight management in adults with obesity or overweight with at least one weight-related condition.

Related: Novo Nordisk seeks weight loss indication for Ozempic

The weight loss drug will be available later in June. Novo Nordisk’s semaglutide 1 mg injection (Ozempic) was first approved to treat type 2 diabetes in 2017.

“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, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in a press release.

Around 70% of American adults have obesity or overweight, according to FDA.

Wegovy’s safety and efficacy were studied in four 68-week trials. Across the trials in people without type 2 diabetes, an average weight loss of 17-18%sustained over 68 weeks was in patients treated with Wegovy, Novo Nordisk said in a press release.

In another trial of adults with type 2 diabetes, individuals who received Wegovy lost 6.2% of their initial body weight compared to those who received placebo.

Related: Pharma maker pulls weight loss drug over FDA concerns

Wegovy works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake. The medication dose must be increased gradually over 16 to 20 weeks to 2.4 mg once weekly to reduce gastrointestinal side effects.

The prescribing information for Wegovy contains a boxed warning to inform healthcare professionals and patients about the potential risk of thyroid C-cell tumors. Wegovy 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), FDA said.

The medication also contains warnings for inflammation of the pancreas (pancreatitis), gallbladder problems (including gallstones), low blood sugar, acute kidney injury, diabetic retinopathy (damage to the eye's retina), increased heart rate and suicidal behavior or thinking.]

Read more: Diabetes med Farxiga nabs FDA Priority Review for Chronic Kidney Disease