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The FDA has announced the approval of semaglutide 2.4 mg (Wegovy) for chronic weight management in patients with obesity or overweight—the first drug to receive such an approval from the FDA in more than half a decade.
The US Food and Drug Administration (FDA) has made history with the approval of subcutaneous semaglutide 2.4 mg (Wegovy) for chronic weight management in adults with obesity or overweight—making semaglutide 2.4 mg the first once-weekly GLP1-RA to receive such an approval and the first drug treatment to receive FDA approval for chronic weight management since 2014.
The approval, which is based on data from the phase 3 STEP Program, is for use in patients with a BMI of 27 kg/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kg/m2 and indicates the treatment should be used in addition to a reduced calorie diet and increased physical activity.
“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 statement. “FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.”
With the STEP program demonstrating the safety and efficacy of semaglutide 2.4 mg in multiple patient populations with obesity or overweight, the FDA grantedapproval for the agent to Novo Nordisk, who received approval for the semagltudie 1 mg (Ozempic) for treatment in type 2 diabetes in 2017. With each of the 4 STEP trials providing evidence of the drug’s effects in more than 2600 patients with obese or overweight, many are hopeful the drug could help curb the growing obesity epidemic in the US.
Among patients without diabetes in the STEP program, use of semaglutide 2.4 mg was associated with an average weight loss of 17-18% that was sustained over 68 weeks. The most common adverse events seen with semaglutide 2.4 mg were nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, and indigestion.
Additionally, the FDA statement pointed out the prescribing information for semaglutide 2.4 mg contains a boxed warning to inform clinicians and patients about the potential risk of thyroid C-cell tumors and also noted the agent should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
In their own statement, Novo Nordisk expressed optimism about the promise of semaglutide 2.4 mg for chronic weight management and also pointed out they expect the agent to be available in the US in late June 2021.
“The approval of Wegovy™ in the US brings great promise to people with obesity. Despite the best efforts to lose weight, many people with obesity struggle to achieve and maintain weight loss due to physiological responses that favor weight regain,” said Martin Holst Lange, executive vice president, Development at Novo Nordisk. “The unprecedented weight loss for an anti-obesity medication marks a new era in the treatment of obesity, and we now look forward to making Wegovy™ available to people living with obesity in the US”.
This is a breaking news story and will be updated as more information becomes available.