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The NDA submission comes following the results of a phase 3a trial.
Earlier this month, Novo Nordisk announced it submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for subcutaneous semaglutide 2.4 mg for chronic weight management.
The approval of the once-weekly glucagon-like peptide-1 (GLP-1) analogue would be to treat adults with obesity (BMI of at least 30 kg/m2) or overweight (BMI of at least 27 kg/m2) with at least one weight-related comorbidity. Semaglutide 2.4 mg would be used alongside a reduced-calorie diet and increased physical activity.
The NDA submission came following the results of the Semaglutide Treatment Effect in People with obesity (STEP) phase 3a clinical trial of more than 4,500 adults with obesity or overweight. Those who were treated with semaglutide 2.4 mg achieved a statistically significant and superior reduction in body weight compared to placebo.
STEP consisted of four trials, starting with a 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo in nearly 2,000 adults with obesity or overweight. Following STEP 1 was STEP 2, a 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo and once-weekly subcutaneous semaglutide 1.0 mg in more than 1,200 adults with type 2 diabetes and either obesity or overweight.
STEP 3 was a 68-week safety and efficacy trial of subcutaneous semaglutide 2.4 mg versus placebo used alongside intensive behavioral treatment in more than 611 adults with obesity or overweight. The final STEP was a 68-week safety and efficacy trial of semaglutide 2.4 mg versus placebo in more than 800 adults with obesity or overweight who reached the target dose after 20 weeks.
In STEP 1, 3, and 4, there was a reported weight loss of 15-18% for people treated with semaglutide 2.4 mg. Common side effects were gastrointestinal and mild to moderate.
“Obesity is associated with a wide range of serious complications, yet many healthcare providers still do not have sufficient medical options available to help people with this chronic disease,” Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk, said in a press release. “We are excited about the regulatory filing of semaglutide 2.4 mg in the U.S. and we believe once-weekly semaglutide 2.4 mg has the potential to transform the medical management of obesity.”