Australians prescribed semaglutide for weight management will soon have an alternative to weekly injections, after the Therapeutic Goods Administration (TGA) approved a once-daily tablet.
The Wegovy Pill – the first oral GLP-1 RA approved by the TGA for weight management – was added to the Australian Register of Therapeutic Goods on 3 November.
If overseas trends are any indication, pharmacists should prepare for strong interest. Demand for GLP-1 RA medicines rose sharply after the tablet launched in the United States and Europe, with 3 million US prescriptions written in its 5 five months on the market. Novo Nordisk has also named Australia a priority market.
But the tablet won’t simply be a swap for the pen. AP explores what pharmacists need to know.
What’s the indication?
While the injectable formulation of Wegovy is approved for children aged 12 and over, semaglutide tablets are approved for adults only.
The Wegovy Product Information (PI) states that the safety and efficacy of the tablet in children and adolescents under 18 years have not been established.
The tablet carries the same adult indications as the injection:
- chronic weight management: as an adjunct to a reduced-energy diet and increased physical activity in adults with a BMI ≥30 kg/m², or ≥27 kg/m² with at least one weight-related comorbidity
- cardiovascular risk reduction: to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and a BMI ≥27 kg/m², without type 1 or type 2 diabetes.
The semaglutide tablets are included in the TGA’s Black Triangle Scheme and should not be used with any other GLP-1 RA or semaglutide-containing product.
Is it the first oral GLP-1 RA on the Australian market?
No. Oral semaglutide isn’t new to Australia. Rybelsus (semaglutide 3 mg, 7 mg and 14 mg tablets) is already registered for type 2 diabetes.
However, Wegovy Pills are tablets the first oral GLP-1 RA approved for weight loss. It comes in different strengths, has a different indication and a higher maintenance dose to Rybelsus, so the two aren’t interchangeable.
How should it be taken?
Needle-free doesn’t necessarily mean easier. Unlike a weekly semaglutide injection, the tablet must be taken:
- every day
- on an empty stomach (fasting at least 8 hours)
- with strict limits on water (swallowed with up to 120 mL)
- and 30-minutes before injection of food or other medicines.
Exposure can fall up to 34% when taken with other medicines.
What’s the dosing schedule?
Treatment starts at 1.5 mg once daily, with at least 1 month at each step:
- 1 month: 1.5 mg
- 2 months: 4 mg
- 3 months: 9 mg
- maintenance: 25 mg.
Patients should only ever take one tablet a day. And if a dose is missed, patients should skip it and take the next dose the following day.
Is the tablet suitable for everyone using injectable semaglutide?
Not quite. Some patients currently using the injection won’t be able to switch, or may be better staying put, including patients:
- who are adolescents: the injection is approved for patients age 12 and older, but the tablet is only indicated for adults aged 18 and over.
- on high injection doses: the 25 mg tablet is the oral equivalent of the 2.4 mg injection of Wegovy, for example, and there’s no higher tablet dose
- with metabolic dysfunction-associated steatohepatitis (MASH): injectable semaglutide is approved for this indication, but the tablet isn’t
- with complex morning medicine routines: the fasting and 30-minute wait may be hard to manage for those taking several other oral medicines
- taking levothyroxine: the tablet increased thyroxine exposure by 33%, an interaction not seen with the injection, so thyroid parameters may need monitoring.
How much will it cost?
No price has been set for Australia. In the US, the tablet generally costs less than the injection. However, the Pharmaceutical Benefits Scheme only subsidises GLP-1 RAs for people with type 2 diabetes, so Australian patients prescribed the tablet for weight management will pay privately.
When will it reach pharmacies?
There’s no launch date yet. A TGA spokesperson told the ABC the regulator had yet to review the tablet’s packaging and production processes before release.
Are other weight-loss pills on the way?
Yes. Eli Lilly’s oral GLP-1 RA orforglipron (Foundayo) is also awaiting TGA approval. Unlike Wegovy Pill, Eli Lilly said orforglipron, approved by the US Food and Drug Administration in April, can be taken at any time of day with no food or water restrictions.
