Novo Nordisk in Plainsboro received Food & Drug Administration approval for Wegovy to treat adults with obesity.
Wegovy is an injectable and is the first and only obesity drug for once-weekly dosing.
Approximately 42% of American adults have obesity, a chronic disease that is recognized by the Centers for Disease Control and Prevention as an epidemic.
The FDA approval of Wegovy was based on the results of the STEP, or Semaglutide Treatment Effect in People with Obesity clinical trial program, which included four-phase 3a clinical trials involving approximately 4,500 patients.
Patients taking Wegovy with a reduced-calorie meal plan and increased physical activity achieved a significant reduction in body weight compared to patients not receiving Wegovy.
In the STEP 1 trial, results showed that patients taking Wegovy lost 14.9% of body weight at 68-weeks vs. 2.4% of body weight in the placebo group.
According to Dr. Robert Kushner, a professor of medicine and medical education at Northwestern University, Feinberg School of Medicine in Chicago, the Wegovy clinical trials are “the first time we have seen this magnitude of weight loss with a medicine.”
“This approval gives people with obesity a once-weekly, non-surgical option with results that have never been demonstrated with an anti-obesity medicine before,” Kushner said in a prepared statement. “The approval of Wegovy represents a turning point for health care providers to embrace medical management of obesity to help improve chronic weight management for patients.”
Obesity is recognized as a chronic disease and health issue by leading health organizations, including the American Medical Association and the CDC. It has many contributing factors, including genetics, lifestyle and environment.
“It’s remarkable that obesity is still seen as a personal flaw rather than a medical condition requiring treatment, just like any other chronic disease. This disease can negatively impact one’s quality of life, both through societal weight bias and stigma, as well as its association with numerous serious health issues,” said Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition, in a prepared statement. “It’s time that we recognized this national public health crisis and the need for as many tools as possible to address it. Expanding safe and clinically effective treatment options for obesity management is good news for people with obesity and the medical community.”
The most common side effects were nausea, diarrhea, vomiting, constipation, and abdominal pain. However, more serious side effects can occur, including possible thyroid tumors and cancer.
Novo Nordisk plans to launch Wegovy later in June.