The drug, semaglutide, "induces weight loss by reducing hunger, increasing feelings of fullness, and thereby helping people eat less and reduce their calorie intake," according to a company statement.
Novo Nordisk plans to launch the drug, given the brand name Wegovy, later this month in the United States.
The weight loss drug is currently under review by the European Medicines Agency.
Several experts said they this drug has the potential to seriously change care of patients when it comes to weight loss.
Drug Tested in Clinical Trial
The favorable FDA ruling is based on results from four phase III clinical trials that tested the drug's safety and efficacy in more than 4,500 adults with overweight or obesity. The trial participants received either a reduced calorie meal plan and increased physical activity or the lifestyle intervention plus semaglutide.
The results were published in the New England Journal of Medicine, The Lancet , and JAMA in February and March 2021.
In the three of the four trials of individuals with overweight and obesity, those in the semaglutide groups saw 15% to 18% weight loss over 68 weeks.
The dosage was well-tolerated. The most common side effects were gastrointestinal, and they were brief and mild or moderate in severity.
A coauthor of the first trial, Rachel Batterham, PhD, of the Centre for Obesity Research at University College London, said at the time of publication: "The findings of this study represent a major breakthrough for improving the health of people with obesity."
"No other drug has come close to producing this level of weight loss — this really is a game changer. For the first time, people can achieve through drugs what was only possible through weight-loss surgery," she added.
Welcome Addition, But Will Insurance Cover It?
Invited to comment on the FDA approval, Thomas A. Wadden, PhD, from the Perelman School of Medicine at the University of Pennsylvania, and lead author of third trial , said in an email that "semaglutide … appears to be the breakthrough in weight management that health care providers and their patients with obesity have been waiting for."
There are concerns regarding insurance coverage and pricing, Wadden said, potentially blocking use of the drug.
"I hope that the millions of people — in the U.S. and worldwide — who could benefit from this medication eventually will have access to it," said Wadden. "In the U.S., the coverage of anti-obesity medications by insurers and employers will need to improve to ensure this happens, and the medication must be reasonably priced. These changes are critical to making this medication the game changer it could be."
"This approval is an important development," Scott Kahan, MD, director of the National Center for Weight and Wellness in , Washington, D.C., who was not involved in clinical trials of the drug, said similarly told Medscape Medical News in an email.
"In a field with relatively few medication options, the availability of additional obesity pharmacotherapy agents is welcome," he said. "In particular, semaglutide has shown impressive efficacy and safety data; as such it should be a valuable clinical option for many patients."
Though the drug could be a viable option for many patients, access to obesity treatments has traditionally been a challenge, Kahan warned.
"Novo Nordisk's other obesity medication, Saxenda, has been a valuable tool, but one that exceedingly few patients are able to utilize due to minimal insurance reimbursement and very high cost," he said.However, it is concerning that "access to obesity treatments has traditionally been a challenge," Kahan warned. "Novo Nordisk's other obesity medication, Saxenda, has been a valuable tool, but one that exceedingly few patients are able to utilize due to minimal insurance reimbursement and very high cost."
"It remains to be seen how accessible semaglutide will be for patients," according to Kahan. "Still, if the challenge of limited coverage and high cost can be mitigated, this medication has a chance to significantly change the current paradigm of care, which until now has included minimal use of pharmacotherapy outside specialty clinics," he maintained.