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The US Food and Drug Administration (FDA) has accepted Novo Nordisk’s new drug application (NDA) submission for the 25 mg oral formulation of Wegovy (semaglutide) intended for chronic weight management in adult obese or overweight patients with one or more comorbid conditions.
This investigational one-time-a-day treatment aims to minimise the risk of major adverse cardiovascular events in this population and established cardiovascular disease.
The agency’s decision on the NDA is expected in the fourth quarter of this year.
The application for Wegovy is supported by outcomes from the 64-week, controlled, randomised Phase III OASIS 4 trial.
This trial assessed the safety and efficacy of a 25 mg dose of oral semaglutide against a placebo in 307 adults without diabetes who were either obese or overweight with at least one comorbidity.
The trial participants underwent a 12-week dose escalation period, with 64 weeks of treatment and a follow-up period of a seven-week off-treatment.
Novo Nordisk noted that, on approval, the therapy would mark the first oral glucagon-like peptide-1 (GLP-1) medication for chronic weight management.
Recently, the company announced that starting July 1 of this year, Wegovy will be the preferred GLP-1 receptor agonist (RA) on the template formularies of CVS Caremark, the US pharmacy benefit manager (PBM).
Currently, the therapy is approved as a 2.4 mg dosage injection for use alongside a low-calorie diet and increased physical activity in the adult and paediatric population aged 12 and above with obesity or overweight with weight-related medical problems.
Additionally, in adults with a history of heart disease who are either obese or overweight, it is used to diminish the risk of cardiovascular incidents, such as heart attacks, strokes, or mortality.
Novo Nordisk Clinical Development, Medical & Regulatory Affairs senior vice president Anna Windle said: "We are entering a new era of obesity care where patients want individualised treatment plans that address their needs and provide choices, including oral formulations.
"We are pleased that the FDA has accepted our submission and look forward to working with regulatory authorities on what would be the first oral GLP-1 treatment for obesity."
Last month, the company invested $1.09bn to expand its production facility in Brazil as a part of the company's strategy to increase the production capacity of its GLP-1 receptor agonist products.
"FDA accepts Novo Nordisk’s NDA submission for weight management therapy" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.