With some 70% of American adults being classified as either obese (42%) or overweight (28%), the battle to stem this epidemic received a new weapon last month: FDA approval of semaglutide, an injectable drug made by the pharmaceutical company Novo Nordisk, for the use of weight-loss in those with a body-mass index (BMI) of 30 or more.
In a statement announcing the approval, Dr. John Sharretts, deputy director of the Division of Diabetes, Lipid Disorders and Obesity in the FDA’s Center for Drug Evaluation and Research, said, “Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program. FDA remains committed to facilitating the development and approval of additional safe and effective therapies for adults with obesity or overweight.”
Semaglutide was first granted FDA approval as a type 2 diabetes medication — albeit at a lower dosage (1 mg) than for obesity — in 2017. This version of the drug is sold as Ozempic.
The new drug — which is to be administered in weekly under-the-skin 2.4 mg injections — is called Wegovy.
As the FDA explained, “Wegovy’s safety and efficacy were studied in four 68-week trials. More than 2,600 patients received Wegovy for up to 68 weeks in these four studies and more than 1,500 patients received placebo.”
According to ABC News, more than half of the studies’ participants lost 15% of their body weight and more than a third of them lost at least 20% of their body weight.
Overall, on average, individuals who received Wegovy lost 12.4% of their initial body weight compared to those who received a placebo.
Researchers from North-western University who participated in the phase 3 clinical trials of the drug called Wegovy “groundbreaking” and a “game changer.”
As Dr. Robert F. Kushner, a Northwestern University School of Medicine professor, obesity specialist and trial investigator told ABC News, “We don’t use those terms lightly. It results in … weight loss of an average of 15% or more, which we have not seen before.”
Dr. Vineeth Mohan, chairman of the Department of Endocrinology and Metabolism at Cleveland Clinic Weston, explained how the drug is believed to work: “Semaglutide mimics a naturally occurring gut-derived hormone called GLP-1. GLP-1 is released while eating and has multiple effects. GLP-1 has an important role in blood sugar regulation in response to meals. It also was found to directly inhibit the brain’s appetite center as well as to slow down stomach emptying. As a consequence, this hormone is one of the signals telling us that we are full after a meal.”
Thus, researchers believe that a person on the drug will tend to feel less general hunger and gain a sense of fullness from smaller, lower-calorie meals.
Mohan noted that another daily injectable drug — liraglutide (sold as Saxenda, also by Novo Nordisk) — has been available as a weight-loss medication since 2014 but whose results have not been as impressive as semaglutide.
According to the FDA, the phase 3 clinical studies found that the most common side effects were nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, indigestion, dizziness, abdominal distension, belching, hypoglycemia (low blood sugar) in patients with type 2 diabetes, and other forms of minor gastric distress.
On a wholly anecdotal note, Mohan said that “I’ve had a small number of patients on the version of semaglutide approved for type 2 diabetes who experience a complete loss of pleasure when eating. They found that they can no longer enjoy mealtimes as they once did, which led to discontinuing the drug. However, this has occurred in just a very few patients over the years.”
For patients who do go on Wegovy, they should expect it to be a long-term protocol.
“A short-term use of semaglultide would be expected to produce short-term weight loss, followed by rapid weight regain unless substantial lifestyle modifications are not concurrently made and continued,” said Mohan.
The fact is, Mohan explained, obesity is usually a long-term, chronic medical condition that usually requires lifelong intervention through lifestyle modification and sometimes medical or surgical intervention.
Like most weight-loss experts, Mohan first wants his overweight and obese patients to attempt diet, exercise and lifestyle modifications to positively impact their weight and overall health.
“I see drug therapy as an adjunct to diet and exercise, and not a replacement for lifestyle change,” he explained. “In my own practice, I’d envision using the drug for patients with concurrent diabetes where the drug would serve a dual role of lowering blood sugar and managing weight.”
However, there is one concern that Mohan and other physicians, as well as their patients, will certainly have about Wegovy: the cost.
While Novo Nordisk has not released the price of the drug, the company did indicate that it expected Wegovy to be priced similarly to Saxenda — which runs approximately $1,350 for a 30-day supply.
“Unfortunately, insurers have historically been reluctant to cover the cost of medications for the treatment of obesity which are often borne as out-of-pocket expenses for patients,” noted Mohan. “Perhaps, given the more impressive weight-lowering effects of this drug, the barriers to drug coverage will change — but I will only believe it when I see it!”