Regulators on Friday said a new version of a popular diabetes medicine could be sold as a weight-loss drug in the U.S.
The Food and Drug Administration approved Wegovy, a higher-dose version of Novo Nordisk’s diabetes drug semaglutide, for long-term weight management.
In company-funded studies, participants taking Wegovy had average weight loss of 15%, about 34 pounds (15.3 kilograms). Participants lost weight steadily for 14 months before plateauing. In a comparison group getting dummy shots, the average weight loss was about 2.5%, or just under 6 pounds.
“With existing drugs, you’re going to get maybe 5% to 10% weight reduction, sometimes not even that,” said Dr. Harold Bays, medical director of the Louisville Metabolic and Atherosclerosis Research Center. Bays, who is also the Obesity Medicine Association’s chief science officer, helped run studies of the drug.
Dropping even 5% of one’s weight can bring health benefits, such as improved energy, blood pressure, blood sugar and cholesterol levels, but that amount often doesn’t satisfy patients who are focused on weight loss, Bays said.
Bays said Wegovy appears far safer than earlier obesity drugs that “have gone down in flames” over safety problems. Wegovy’s most common side effects were gastrointestinal problems, including nausea, diarrhea and vomiting. Those usually subsided, but led about 5% of study participants to stop taking it.
The drug carries a potential risk for a type of thyroid tumor, so it shouldn’t be taken by people with a personal or family history of certain thyroid and endocrine tumors. Wegovy also has a risk of depression and pancreas inflammation.
Wegovy (pronounced wee-GOH’-vee) is a synthesized version of a gut hormone that curbs appetite. Patients inject it weekly under their skin. Like other weight-loss drugs, it’s to be used along with exercise, a healthy diet and other steps like keeping a food diary.
The Danish company hasn’t disclosed Wegovy’s price but said it will be similar to the price of its Saxenda, a weight loss drug injected daily that now typically costs more than $1,300 per month without insurance.
Dr. Archana Sadhu, head of the diabetes program at Houston Methodist Hospital, said Wegovy’s usefulness “all depends on what the price will be.” She noted patients’ health insurance plans sometime don’t cover weight-loss treatments, putting expensive drugs out of reach.
Sadhu, who has no connection to Novo Nordisk, plans to switch patients who are obese and have Type 2 diabetes to Wegovy. It makes patients feel full sooner and increases release of insulin from the pancreas to control blood sugar, she said. Patients would then be more likely to get motivated to exercise and eat healthier, she added.
Wegovy builds on a trend in which makers of relatively new diabetes drugs test them to treat other conditions common in diabetics. For example, popular diabetes drugs Jardiance and Novo Nordisk’s Victoza now have approvals for reducing risk of heart attack, stroke and death in heart patients.
Phylander Pannell, 49, of Largo, Maryland, joined a patient study after cycles of losing and then regaining weight. She said she received Wegovy, worked out several times a week and lost 65 pounds over 16 months.
“It helped curb my appetite and it helped me feel full faster,” said Pannell. “It got me on the right path.”
Shortly after she finished the study and stopped receiving Wegovy, she regained about half the weight. She’s since lost much of that, started exercise classes and bought home exercise equipment. She’s considering going back on Wegovy after it’s approved.
Novo Nordisk also is developing a pill version.
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Wegovy™ (the brand name for once-weekly semaglutide 2.4 mg injection in the US) for chronic weight management. Wegovy™ is indicated as an adjunct to diet and exercise for chronic weight management in adults with obesity (initial BMI≥30 kg/m2) or overweight (initial BMI≥27 kg/m2) with at least one weight-related comorbidity.
Wegovy™ is the first and only once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist therapy approved for weight management for people living with obesity. The approval is based on the results from the STEP phase 3a clinical trial programme. Across the trials in people without type 2 diabetes, an average weight loss of 17-18%1 sustained over 68 weeks was reported for people with obesity treated with Wegovy™. Wegovy™ demonstrated a safe and well-tolerated profile across the programme, with the most common adverse events being gastrointestinal.
“The approval of Wegovy™ in the US brings great promise to people with obesity. Despite the best efforts to lose weight, many people with obesity struggle to achieve and maintain weight loss due to physiological responses that favour weight regain,” said Martin Holst Lange, executive vice president, Development at Novo Nordisk. “The unprecedented weight loss for an anti-obesity medication marks a new era in the treatment of obesity, and we now look forward to making Wegovy™ available to people living with obesity in the US”.
Novo Nordisk expects to launch WegovyTM in the United States later in June 2021.
About Wegovy™ (semaglutide 2.4 mg) and STEP
Semaglutide 2.4 mg is a GLP-1 receptor agonist, with 94% similarity to naturally occurring human GLP-1 hormone. It induces weight loss by reducing hunger, increasing feeling of fullness and thereby helping people eat less and reduce their calorie intake. Once-weekly semaglutide 2.4 mg injection is approved for the treatment of adults with obesity or overweight in the US, in addition to diet and exercise.
Semaglutide 2.4 mg for weight management is currently under regulatory review in the EU and other countries. The submissions are based on the results from the STEP (Semaglutide Treatment Effect in People with obesity) phase 3 clinical development programme. The global clinical phase 3a programme consists of four trials and enrolled approximately 4,500 adults with overweight or obesity.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 45,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.
|Mette Kruse Danielsen||+45 3079 3883||[email protected]|
|Michael Bachner (US)||+1 609 664 7308||[email protected]|
|Daniel Muusmann Bohsen||+45 3075 2175||[email protected]|
|Ann Søndermølle Rendbæk||+45 3075 2253||[email protected]|
|David Heiberg Landsted||+45 3077 6915||[email protected]|
|Mark Joseph Root (US)||+1 848 213 3219||[email protected]|
Company announcement No 38 / 2021