Novo Nordisk eyes EU approval for once-weekly semaglutide

Danish pharma company Novo Nordisk has submitted a marketing authorisation application the European Medicines Agency (EMA), seeking approval for once-weekly semaglutide for weight management.

The glucagon-like peptide-1 (GLP-1) analogue, administered once-weekly at a 2.4mg dose, is being investigated by Novo Nordisk as a potential treatment for obesity.

The potential indication is for the treatment of adults with obesity or who are overweight, with at least one weight-related comorbidity, alongside a reduced-calorie diet and increased exercise.

The EMA submission is based on data from Novo’s STEP phase 3a trial programme, which involved over 4,500 adults with obesity or who were overweight.

Across this clinical programme, people with obesity who receive once-weekly semaglutide 2.4mg achieved a statistically significant and reduction in body weight compared to placebo.

Across the trials in people without diabetes, a weight loss of 15-18% was reported for those treated with once-weekly semaglutide.

In addition, the treatment appeared to have a safe and well-tolerated profile in these trials, with the most common side effects being gastrointestinal – although these were transient and mild or moderate in severity.

“We are excited about this regulatory filing following the recent regulatory filing with the FDA in the US,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk.

“It is a milestone for Novo Nordisk but more importantly it represents a new treatment option with the potential to transform the medical management for people living with obesity in Europe,” he added.

Earlier this month, Novo also filed for US Food and Drug Administration (FDA) approval for the once-weekly semaglutide treatment regimen for weight management.

Novo applied a priority review to the new drug application in the US, meaning that the anticipated review time will be six months from the submission date – according to standard FDA review timelines.

Oral semaglutide is already marketed in the EU under the brand name Rybelsus for type II diabetes, as an adjunct to diet and exercise for adults whose condition remains uncontrolled.