Novo Nordisk's Semaglutide Receives FDA Approval as First New Obesity Treatment Since 2014

On June 4, 2021, the U.S. FDA approved Wegovy (semaglutide) injection (2.4 mg once weekly), developed by Novo Nordisk, for chronic weight management in adult patients with obesity or overweight who have at least one weight-related condition, to be used in conjunction with a reduced-calorie diet and increased physical activity. The press release noted that this subcutaneous injection is the first new drug approved by the U.S. FDA for managing general obesity or overweight since 2014. It is indicated for overweight patients with a body mass index (BMI) greater than 27 who have at least one weight-related disease, or for obese patients with a BMI greater than 30.

Based on Phase 3 clinical trial data, over a 68-week trial period, Wegovy helped one-third of patients with obesity lose more than 20% of their body weight. Patients with obesity without type 2 diabetes lost an average of 17% to 18% of their body weight.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that stimulates insulin secretion, inhibits glucagon secretion, and reduces appetite and food intake. Previously, the drug had already received FDA approval for the treatment of patients with type 2 diabetes. In December 2020, Novo Nordisk submitted an application to the FDA for the approval of semaglutide for the treatment of obesity, utilizing a Priority Review Voucher to expedite the FDA approval process. With this "game-changing" approval, Novo Nordisk will disrupt the vast and largely untapped obesity market, where patients have long had few attractive treatment options.

Novo Nordisk's other weight-loss medication, Saxenda, helps patients achieve an average weight loss of 5% of their body weight, while the weight-loss data demonstrated by Wegovy are even more impressive. Currently, Wegovy appears poised to dominate the obesity market; however, it may ultimately face competition from Eli Lilly's dual GIP/GLP-1 receptor agonist, tirzepatide. Eli Lilly is advancing the drug through clinical trials for the treatment of type 2 diabetes. In a recent head-to-head clinical trial, the novel agent demonstrated superior weight-loss efficacy compared to 1 mg of semaglutide (with Wegovy administered at a 2.4 mg dose).

Wegovy is the injectable formulation of semaglutide. Novo Nordisk is already looking ahead, evaluating more convenient delivery methods. In the second half of 2021, Novo Nordisk planned to enroll approximately 1,000 patients in a Phase 3a clinical trial to assess the safety and efficacy of 50 mg oral semaglutide in patients with overweight or obesity and comorbidities.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014

Responsible Editor: Liuli

Disclaimer: This article consists of content compiled by Yaozhi.com. Copyright belongs to the original authors. The content is disseminated for informational purposes only and does not represent the views of this platform. Should any issues arise concerning content, copyright, or other matters, please contact us by leaving a message on this website, and we will promptly remove the content.