DENMARK – Novo Nordisk, a Danish drug company that focuses on lifestyle related diseases, has finally received the US Food & Drug Administration (USFDA) approval of its weight management drug, Wegovy.
The drug Wegovy (brand name for once-weekly semaglutide 2.4 mg injection in the US), was developed to be an adjunct to diet and exercise for chronic weight management in obese adults.
Wegovy will be the first and only once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist therapy approved for weight management for people living with obesity across the world.
Approval was based on data received from the STEP phase 3a clinical trials that was conducted back in April 2021.
The STEP phase 3a clinical trials programme was part of a global 68 – weeks program and it involved approximately 1000 people living with obesity or those who were overweight with comorbidities. Investigations of the trials was based on the efficacy and safety of the drug compared to placebo.
Across the trials in people without type 2 diabetes, an average weight loss of 17-18% sustained over 68 weeks was reported for people with obesity treated with Wegovy.
Hence Wegovy demonstrated a safe and well-tolerated profile across the programme, with the most common adverse events being gastrointestinal.
Obesity is a chronic disease that requires long-term management and is associated with many serious health complications and decreased life expectancy.
Its related complications are numerous and include type 2 diabetes, heart disease, obstructive sleep apnea, non-alcoholic fatty liver disease and certain types of cancer.
The current COVID-19 pandemic has highlighted that obesity also increases the risk for severe illness and hospitalization due to COVID-19.
Global increase in the prevalence of obesity is a public health issue that has severe cost implications to healthcare systems. Approximately 650 million adults are estimated to live with obesity worldwide.
Novo Nordisk has been in the fore front in trying to eradicate obesity globally through the use of weight management therapy.
Currently, the company is also launching an accelerator programme, dubbed prevention accelerator that is inviting start-ups developing digital solutions from around the globe to submit ideas on how they can enable individuals and/or societies to predict and/or prevent obesity.
The Prevention Accelerator will support each of the two best ideas with up to US$100,000 to pilot their solutions with Novo Nordisk.
After months of hard work, the teams will participate in a demo day in February 2022 to showcase their solutions to wider Novo Nordisk organization.