Medicine has certainly evolved. Gone are the days, and farewell to them, when medical care meant completely entrusting your health to someone else. Nowadays, you can learn about medical conditions, diagnoses, and treatments online. As an informed consumer, you can investigate your symptoms, research your treatment options, and consult with a healthcare provider.
If you have been struggling with overweight and obesity and are ready to consider whether an obesity drug could help you, it is important to understand what FDA approval means for a medication and why some medications are approved while others are not.
On June 4th, 2021, the FDA approved Wegovy, generic name semaglutide, for weight management.
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It is a multi-step process for a drug to become FDA-approved. The drug manufacturer must demonstrate that the drug is safe for you to take and that it works well to treat a specific medical condition.
To be FDA-approved, a drug manufacturer must submit data on its effects to the FDA’s Center for Drug Evaluation and Research (CDER). To obtain the necessary data, pharmaceutical companies must first test their products on specific populations for specific reasons. Testing begins with animal testing, then progresses to human safety testing, and finally to efficacy testing. This procedure usually entails a series of clinical trials.
A team of physicians, statisticians, chemists, pharmacologists, and other scientists at CDER review the data from the animal and human trials. They also review the proposed drug labeling to ensure the claims made by the company align with the testing that was done.
If CDER scientists determine that the drug’s health benefits outweigh its known risks, it will be approved for sale.
The FDA examines the current medical situation as well as the drug landscape. While there are several obesity drugs sold for weight management, most of them deliver about a 5% reduction in weight when combined with a low-calorie diet and exercise.
Three-quarters of all adults in the United States are overweight or obese. A 5% weight loss will not be enough to bring most people into a healthy weight category and lower their risk of chronic disease.
The FDA might consider the lack of more effective medications and the high rate of obesity in the U.S. when it sets the bar for tolerable risks for an obesity drug, like Wegovy.
Once scientists from the FDA have surveyed the current drug landscape, they assess the risks and benefits reported from the clinical trials and CDER’s evaluation. The FDA likes to see at least two well-designed clinical trials to ensure the results aren’t due to chance alone. To test Wegovy, Novo Nordisk scientists have run eight STEP trials, a STEP TEENS trial, and a SELECT Wegovy clinical trial. There are currently 236 studies registered on clinicaltrials.gov that mention semaglutide.
Next, the FDA determines how the drug manufacturer will mitigate risks from their drugs. All drugs have risks, including over-the-counter medications, supplements, prescription medications, and medications sold off-label.
If a healthcare provider chooses to prescribe a medication for an unapproved indication, dosage, age group, or route of administration because they believe the benefits outweigh the risks in treating your medical condition, they can prescribe the drug off-label.
This is a very common practice because it does not make financial sense for pharmaceutical companies to test their drugs for every potential indication, dosage, age group, and delivery method.
Once the FDA finishes its review and deliberations and makes a decision using the best-known scientific and technological information available, the drug may be approved.
Novo Nordisk has already manufactured and sold FDA-approved Ozempic since 2017 and Rebelsus since 2019. Ozempic and Rebelsus are also semaglutide, but they are offered in different dosages and for different medical indications than Wegovy. Ozempic and Rebelsus are oral medications to lower blood sugar and A1C in people with type 2 diabetes. Novo Nordisk sought a separate medical indication for chronic weight management at a higher dose and as an injectable.
Wegovy moved through a series of four clinical trials called the Semaglutide Treatment Effect in People with Obesity (STEP) clinical trials to be approved as an obesity drug. The initial STEP series consisted of four 68-week randomized, double-blind clinical trials that enrolled approximately 4,500 people who were overweight or obese. The results of these clinical trials showed that participants using 2.4 mg of semaglutide subcutaneous injections once per week lost between 15% and 20% of their body weight.
The FDA approved Wegovy in June 2021. There has not been another drug approved for weight management since 2014. There are currently ten FDA-approved obesity drugs in the U.S. Several other medications, such as metformin, are used off-label to treat obesity.
Wegovy has two medical indications for chronic weight management in people with a body mass index (BMI):
Obesity is a serious chronic medical condition that increases your risk for:
The FDA considered these risks when weighing the risks versus benefits before granting its approval for Wegovy as an obesity drug.
Wegovy and other semaglutide drugs are glucagon-like peptide-1 (GLP-1) receptor agonists. These medications target areas of the brain that regulate appetite and food intake. The most common side effects of Wegovy are gastrointestinal. This is why the medication dose is gradually increased over 16 to 20 weeks to reach the recommended dose of 2.4 mg once weekly.
Known side effects associated with Wegovy include:
Wegovy carries a black-box warning about its potential to increase the risk for thyroid C-cell tumors. If you have a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, you should not take Wegovy. You should also not take Wegovy if you have a known allergy to semaglutide or any of the drug components.
Tell your doctor about your medical history and current medications to help them ensure that you are not in a higher risk category if you take Wegovy.
This is a question that only you and your healthcare provider can answer. If you provide your healthcare provider and pharmacist with a complete medical history, they will have the best information possible to weigh the risks and benefits of taking Wegovy.
The FDA weighs the risks and benefits of a new medication for an entire population. You and your doctor do the same on an individual basis. We encourage you to contact one of the healthcare providers at Invigor Medical to learn more about how Wegovy, an obesity drug, may benefit you.
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While we strive to always provide accurate, current, and safe advice in all of our articles and guides, it’s important to stress that they are no substitute for medical advice from a doctor or healthcare provider. You should always consult a practicing professional who can diagnose your specific case. The content we’ve included in this guide is merely meant to be informational and does not constitute medical advice