On June 4, 2021, the FDA announced the long-awaited approval of Wegovy, a once-weekly injectable drug for weight loss.
In the months leading up to clearance, Wegovy received a lot of press, with a New York Times piece calling it a "game changer," MedPage Today reporting "extraordinary outcomes," and the BBC claiming it might usher in a "new era" in obesity treatment. Wegovy's efficacy has been lauded in the media as being superior to any other weight-loss medicine now on the market. Such spectacular headlines are typical in the media, so we must consider if all of the media attention is genuinely justified.
What exactly is Wegovy and how does it function?
Wegovy is the brand name for semaglutide, a high-dose injectable peptide hormone molecule that was previously approved by the FDA for the treatment of type 2 diabetes under the trade names Rybelsus (oral) and Ozempic (lower-dose injection).
The higher-dose Wegovy allows for the better crossing of the blood-brain barrier, which increases its weight-loss efficacy. Injectable semaglutide eliminates the strict guidelines for ingesting on an empty stomach required by oral semaglutide, while the higher-dose Wegovy allows for the better crossing of the blood-brain barrier, which increases its weight-loss efficacy.
Semaglutide belongs to the glucagon-like peptide-1 receptor agonists or GLP-1 RAs, class of drugs. GLP-1 is a hormone that is produced naturally in the gastrointestinal tract in response to food intake. It has several effects, including boosting pancreatic insulin release, slowing stomach emptying, and reducing appetite through targeting brain receptors. This causes a feeling of satiety, or fullness, that lasts significantly longer than natural GLP-1 hormone levels.
Who will be able to take Wegovy?
Wegovy, like all other prescription drugs for the treatment of obesity, is licensed for use in those who have a BMI of 30 kg/m2 or higher.or those with a BMI of 27 kg/m2 and a weight-related medical condition such as hypertension, type 2 diabetes, or high cholesterol.
What are the disadvantages and advantages of Wegovy?
The STEP (Semaglutide Treatment Effect in People with Obesity) trials, Wegovy's phase 3 clinical trials, were undertaken in several clinical settings, each with modest differences in the study population and research design. The STEP 1 experiment, whose findings were published in the New England Journal of Medicine, found that those assigned to the pharmaceutical group lost an average of 14.9 percent of their body weight after 68 weeks of therapy, compared to only 2.4 percent for those assigned to the control group.
Nausea, diarrhea, vomiting, and constipation are the most common adverse effects of Wegovy. The prescription also comes with a warning about the possibility of a specific thyroid tumor, so it's not suggested for anyone who has a personal or family history of medullary thyroid cancer or type 2 multiple endocrine neoplasias (a genetic condition associated with endocrine tumors). It's worth noting that tumors were only seen in animal experiments and not in human trials.
How long do you think you'll be able to keep Wegovy?
Wegovy is one of six obesity drugs now approved by the FDA for long-term use.As a result, it can be used indefinitely as long as it is effective for weight loss and/or maintenance and does not cause unacceptable adverse effects. Exenatide was the first GLP-1 RA medicine to receive FDA approval in 2005;
since then, other GLP-1 RAs have been licensed and have undertaken long-term trials indicating either non-inferiority or superiority to placebo for major adverse cardiovascular events like heart attacks and stroke. The SELECT trial is a long-term cardiovascular outcomes trial for Wegovy that is underway and projected to be finished in September 2023.
Management of anti-obesity medications is changing.
Wegovy is the latest in a long line of drugs approved by the FDA for the treatment of obesity, beginning with phentermine in 1959. In the United States, phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, phentermine/topiramate ER (Qsymia), bupropion/naltrexone (Contrave), liraglutide (Saxenda), setmelanotide (Imcivree), and recently semaglutide have all been authorized by the FDA (Wegovy).
Setmelanotide, it should be noted, is only licensed for the treatment of obesity caused by uncommon hereditary disorders. Metformin, zonisamide, and other GLP-1 RAs are commonly used to treat diabetes.
Many cases of therapeutics failing to demonstrate sufficient safety data to warrant FDA approval, such as rimonabant (Acomplia), or adverse effects necessitating market withdrawal, such as lorcaserin (Belviq), sibutramine (Meridia), dexfenfluramine (Redux), fenfluramine (Pondimin), and the infamous combination medic. Unfortunately, the rocky anti-obesity pharmaceutical landscape causes doctors to be hesitant to use the many safe and effective tools available today to treat obesity.
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