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Wegovy (semaglutide)
Australian Prescription Medicine Decision Summary
Wegovy is approved in a new form (tablet) for adults, as an adjunct to a reduced-energy diet and increased physical activity for chronic weight management, and as an adjunct to standard of care therapy, to reduce the risk of major adverse cardiovascular events. Wegovy contains the active ingredient semaglutide.
Published
Product name
Wegovy
Active ingredient
Semaglutide
Submission type
New dosage form (tablet) - Type F application
Decision
Approved for registration in the Australian Register of Therapeutic Goods (ARTG)
Decision date
Registration date
What this medicine was approved for
Wegovy tablets are approved for adults in 4 strengths (1.5 mg, 4 mg, 9 mg and 25 mg) for:
- chronic weight management, including weight loss and maintaining a healthy weight, in combination with a reduced energy diet and increased physical activity
- lowering the risk of serious cardiovascular events in people who already have cardiovascular disease. These may include death from a cardiovascular problem, or a non-fatal heart attack or stroke events. This medicine works best in combination with standard of care therapy.
Wegovy can be prescribed for weight management, specifically for patients diagnosed as obese with a Body Mass Index (BMI) equal to or greater than 30, or overweight with a BMI equal to or greater than 27, with one weight-related health issue.
Wegovy can be prescribed for patients wanting to lower the risk of serious cardiovascular problems, with a BMI equal to or greater than 27 that do not have Type 1 or Type 2 diabetes.
Overweight and obesity are long term health conditions, resulting from genetic, metabolic, environmental and behavioural factors. These factors can increase the risk of illness and reduced life expectancy.
Wegovy contains semaglutide, a human glucagon-like peptide-1 (GLP-1), already approved and registered in Australia as an injection. The tablets offer an alternative treatment option, instead of the injection.
How this medicine works
Semaglutide is similar to a natural hormone in the body called GLP-1. Semaglutide attaches to and activates GLP-1 receptors in the body.
Naturally occurring GLP-1 helps control blood sugar and appetite. It acts on GLP-1 receptors in the pancreas and brain, but receptors are also found in the heart, blood vessels, immune system and kidneys. GLP-1 may help protect the heart and small blood vessels through these receptors.
Compared to naturally occurring GLP-1, which is active for a very short time in the bloodstream, semaglutide stays in the body for about 1 week. Semaglutide attaches to a protein in the blood called albumin. This ensures that the kidneys remove it more slowly and protects it from breaking down.
Semaglutide can help people lose body weight and body fat by reducing how much they eat. It can reduce appetite and hunger, help people feel full, improve regulation of food intake or reduce overeating and reduce food cravings. Weight loss with semaglutide may also help reduce insulin resistance.
Semaglutide can also reduce a person’s preference for high-fat foods. In clinical studies, semaglutide improved blood fat levels, lowered blood pressure and reduced inflammation.
Why the TGA approved or did not approve this medicine
The effectiveness and safety of Wegovy, in tablet form, for weight management were assessed in one main clinical study called the OASIS-4 study, and three supporting studies called the PIONEER PLUS study, OASIS-2 and OASIS-3 studies. Further support was provided from the STEP 1-4 programme with semaglutide 2.4 mg injection.
- OASIS-4 study: Multi-centre and multinational study assessing the effectiveness and safety of oral semaglutide 25 mg once daily versus a placebo (a tablet containing no active ingredients), in adults, in combination with a reduced-calorie diet and increased physical activity.
- PIONEER PLUS study: Multi-centre study assessing the effectiveness and safety of oral semaglutide 25 mg and 50 mg versus 14 mg taken once daily by participants with type 2 diabetes.
- OASIS-2 and OASIS-3 studies: Effectiveness and safety of oral semaglutide 50 mg once daily in adults with overweight or obesity.
The effectiveness and safety of Wegovy, in tablet form, for lowering the risk of serious cardiovascular events were assessed in one main clinical study called the SOUL study. Further supporting evidence from studies, such as the SELECT Study using semaglutide 2.4 mg injection, showed reduced risk of major adverse cardiovascular events in adults with overweight or obesity and established cardiovascular disease, but without diabetes.
- SOUL Study: A placebo-controlled trial assessing the effectiveness and safety of oral semaglutide (tablet) versus placebo, with both administered once daily and added to standard of care in patients with type 2 diabetes at high risk of cardiovascular events.
Key findings from clinical studies
- 76.3% of participants taking semaglutide 25 mg tablet once daily, in combination with a reduced-calorie diet and increased physical activity, achieved weight loss (5% or greater) compared to those taking the placebo (30.5%). These results were statistically meaningful.
- Participants taking 25 mg semaglutide tablet once daily showed statistically meaningful results with a 5% or greater reduction in body weight, when compared to placebo.
- Furthermore, participants across the clinical studies taking oral semaglutide 25 mg achieved equal to or greater than 5%, 10% and 15% weight loss with Wegovy compared with placebo. All these results were statistically meaningful.
- Treatment with Wegovy also showed statistically significant improvements in waist circumference and systolic blood pressure compared to placebo.
- The OASIS-4 study demonstrated improvements in physical function according to the Impact of Weight on Quality of Life‐Lite Clinical Trials Version (IWQOL‐Lite-CT) survey when comparing the participants taking oral semaglutide 25mg, to participants taking the placebo, after week 32.
- The proportion of participants who experienced a first major adverse cardiovascular event or serious cardiovascular problem, was lower with oral semaglutide (12%) than with placebo (13.8%).
- Participants who were taking oral semaglutide, compared to those taking the placebo, also experienced less non-fatal strokes and heart attacks and less cardiovascular disease related deaths.
- Most of the reported side effects (adverse or undesirable events) were non-serious and of mild or moderate severity. The most commonly reported side effects included nausea and vomiting, constipation, indigestion, diarrhoea, belching/ burping, abdominal pain, headache, dizziness and fatigue.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Wegovy, containing semaglutide in tablet form, and the oral medicine can be registered in Australia.
More detailed information on why the TGA approved Wegovy will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
Australian CMIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
Australian PIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For free health advice or to speak to a registered nurse about any health concern call the 1800MEDICARE helpline.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.
Using Wegovy (semaglutide) tablets or injections at the same time as other medicines containing semaglutide, or other medicines called GLP-1 receptor agonists, is not recommended.