Novo Nordisk gets FDA-approval for Wegovy as a new treatment for chronic weight management

Last Friday, Novo Nordisk announced that the FDA approved their new drug application for Wegovy®. (semaglutide), the first and only prescription weight-loss medication with once-weekly dosing.

This is very exciting news, because, in clinical trials, adults with obesity who took Wegovy for weight loss (and followed a reduced-calorie and increased physical activity plan) lost an average of 15% of their initial weight after 68 weeks. This represents an average weight loss far greater than seen in studies for any other medication currently approved for weight loss.

Currently, the drug is approved but not yet available to the public, but as it hits the market, we will continue to keep you updated. Today, our Chief Medical Officer, Dr. Florencia Halperin, gives us some background on semaglutide and why this recent development in this field is so important.

We hope you’ll learn a thing or two!

The quick science of semaglutide

Semaglutide is in a class of medications called glucagon-like peptide-1 receptor agonists (GLP-1 RAs). GLP-1 is a hormone that our bodies make. This hormone interacts with the pancreas (which secretes insulin) and other organ tissues that regulate blood sugar. It also affects the networks in our brain that regulate hunger and fullness.

The GLP-1 RA medications are chemically very similar to the natural hormone and mimic its actions in the body. Because of the effect on blood sugar regulation, these medications are an effective treatment for type 2 diabetes. And because they help people be less hungry, they promote weight loss.

Let’s break this down a bit more.

Semaglutide has been available to treat diabetes

The development of semaglutide was a significant advancement in the treatment of type 2 diabetes. First, semaglutide is more effective at improving blood glucose control than many other medication options. But beyond blood sugar lowering, an equally important goal of diabetes treatment is to prevent the serious health complications that diabetes can lead to. So it was very impactful when studies showed that semaglutide (compared to other diabetes medications) reduces the risk of diabetes complications -- including developing a cardiac event or a cardiac death. Plus, semaglutide is a GLP-1 RA that you only have to inject once per week, instead of daily, which people who have to do injections obviously prefer. And more recently, an oral formulation of semaglutide was approved for diabetes as well.

So, semaglutide helps treat diabetes and assist with weight loss?

Yes! Another key reason why semaglutide and other drugs like it have been such a tremendous advance in diabetes treatment is that in addition to improving blood sugars and diabetes outcomes, they also assist with weight loss. Other diabetes drugs can be associated with weight gain, so the fact that these medications help people lose weight makes them an especially good option for the many people who have both diabetes and obesity.

So why all the buzz, what is new about semaglutide now?

We already know that people with diabetes who take semaglutide have improved blood sugar control, reduced diabetes complications, and they lose weight. But the exciting recent development is about using semaglutide for weight loss in people without diabetes.

Very recent studies showed that those who followed a healthy lifestyle plan and took semaglutide lost much more (about 15%) of their starting weight compared to people who followed the same lifestyle plan but injected a placebo. This degree of weight loss is more than has been seen in any study of the medications currently on the market for weight loss; it even approaches the amount of weight loss that results from weight loss surgery. Those taking semaglutide reported less hunger, fewer food cravings, and better control of eating as they were losing weight.

It turns out that the semaglutide dose that works best for weight loss is much higher than the dose that works best for blood sugar control. While the approved dose for diabetes is 1 mg per week, the dose for chronic weight management just approved as Wegovy by the FDA is 2.4 mg per week.

Since semaglutide works so well for diabetes, you might also be wondering whether it dangerously lowers blood sugars in people without diabetes. It does not, and it was important to do the safety clinical trials to be sure of this.

What are other drug treatments for obesity and how significant will it be to add semaglutide to the list?

There are multiple medications with FDA approval for weight loss. Phentermine is a stimulant drug, and the only one available as a generic. Other brand-name options include Qsymia (phentermine/topiramate), Contrave (bupropion/naltrexone), and Saxenda (liraglutide), the only GLP1-RA currently approved for weight loss.

The reason that semaglutide is being called a game-changer is first and foremost the amount of weight loss observed - significantly more than had been observed in prior weight loss drug studies, including with liraglutide (Saxenda). And it has to be injected less frequently.

Because I have been prescribing semaglutide to my patient with diabetes for years, I know that it helps people be less interested in food and full from smaller portions. So they are not uncomfortably hungry or feeling deprived, as they might have if dieting. And they lose weight, even if that has been very difficult for them in the past.

So, what’s next?

I’m thrilled to witness a scientific development that may help people who have obesity lead healthier lives. I am looking forward to gaining experience with how the higher doses help my patients. As Wegovy  becomes available in pharmacies, I’ll work with my patients to see if they may be appropriate for this treatment, which is always an individualized decision based on multiple factors. And Form Health is here for anyone who wants to explore a medical approach to weight loss and what treatment path may work best for them.

Increasing treatment options offers new hope to people who want to lose weight to improve their health. I’m also optimistic that these developments will help decrease weight stigma, by advancing the understanding that obesity is a disease, with a biological basis - that’s precisely why medications like Wegovy™ which alter biological pathways, can be effective. We need to move beyond the outdated notions that personal choices or flaws are what determines someone’s weight, and eradicate the judgment and discrimination that we know causes people harm.