Novo Nordisk files for US FDA regulatory approval of once-weekly semaglutide 2.4 mg for weight management
Bagsværd, Denmark, 4 December 2020 – Novo Nordisk today announced the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for subcutaneous
semaglutide 2.4 mg, a once-weekly glucagon-like peptide-1 (GLP-1) analogue for chronic weight management. A priority review voucher has been applied to the NDA, leading to an anticipated
review time of six months from the submission date, according to standard FDA review timelines.
The potential indication is for the treatment of adults with obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) with at least one weight-related comorbidity, as an adjunct to reduced-calorie diet and increased physical activity.
The submission is based on the results from the STEP phase 3a clinical trial programme, which included more than 4,500 adults with obesity or overweight. Across the STEP programme, people with obesity treated with once-weekly semaglutide 2.4 mg achieved a statistically significant and superior reduction in body weight compared to placebo. Across STEP 1, 3 and 4 a weight loss of 15-18% was reported for people treated with semaglutide 2.4 mg. Furthermore, once-weekly semaglutide 2.4 mg appeared to have a safe and well-tolerated profile. The most common side effects were gastrointestinal and were transient, and mild or moderate in severity.
“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 ,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. "We are excited about the regulatory filing of semaglutide 2.4 mg in the US and we believe once-weekly semaglutide 2.4 mg has the potential to transform the medical management of obesity."
About obesity and subcutaneous semaglutide 2.4 mg for weight management
Obesity is a chronic disease that requires long-term management. It is associated with many serious health consequences and decreased life expectancy. Obesity-related complications are numerous and include type 2 diabetes, heart disease, obstructive sleep apnoea, non-alcoholic fatty liver disease and cancer.
Once-weekly subcutaneous semaglutide 2.4 mg is being investigated by Novo Nordisk as a potential treatment for obesity. Semaglutide is an analogue of the human glucagon‑like peptide-1 (GLP-1) hormone. It induces weight loss by reducing hunger, increasing feelings of fullness and thereby helping people eat less and reduce their calorie intake.