The Therapeutic Goods Administration (TGA) has approved the first GLP-1 weight loss tablet for use in Australia, clearing a daily Wegovy pill made by Danish pharmaceutical giant Novo Nordisk for patients with obesity or those requiring cardiovascular risk reduction.
The TGA signed off on Tuesday on the Wegovy pill. Until now, Australians with prescriptions have only been able to use GLP-1 drugs in the form of weekly injections. The decision comes after the pill was approved in the United States and Europe, where demand surged once it hit the market.
A TGA spokesperson said the pill had been approved in four strengths: 1.5 mg, 4 mg, 9 mg and 25 mg. One 25 mg tablet containing semaglutide acts the same as a 2.4 mg injection because the body absorbs active ingredients less efficiently when taken orally.
Patients will need a doctor's prescription. Under current rules, the Pharmaceutical Benefits Scheme (PBS) only subsidises weight loss drugs for people with type 2 diabetes. A price guide has not yet been set for Australia, but in the US the pill generally costs less than the injection.
The TGA is yet to review the packaging and production processes to confirm they meet quality standards before the product can be released. Novo Nordisk has previously flagged Australia as a priority market for the pill, which saw three million prescriptions in the first five months of its availability in the US this year. The company has been contacted for comment.
Rival Eli Lilly, the maker of Mounjaro, has its own oral weight loss drug, Orforglipro, awaiting a decision from the TGA.
Analysis
Why This Matters
- Australian patients with obesity or cardiovascular risk now have an oral option, which may improve adherence compared to weekly injections.
- The tablet could eventually be cheaper than the injection, though pricing is not yet announced; a lower cost may increase access.
- PBS subsidy remains limited to type 2 diabetes patients, leaving many to pay full price until the criteria are reviewed.
Background
GLP-1 drugs such as Wegovy have become popular globally for weight loss and cardiovascular protection. Until now, Australian patients could only receive them via weekly injections. The TGA's approval of the oral version follows similar approvals in the US and Europe, where demand has been high.
What to Watch
- When the TGA clears packaging and production processes, which will determine the launch date.
- Whether Novo Nordisk applies for PBS listing for the pill, which would significantly reduce patient costs.
- Eli Lilly's oral drug Orforglipro, which is under TGA review and could offer further competition.
Checked
12 claims in this story checked against 1 source: 12 supported.
Show each claim
- SupportedThe TGA has cleared the first GLP-1 weight-loss tablet for use in Australia.Just In: “Te first GLP-1 weight loss tablet has been cleared for use in Australia”
- SupportedThe Wegovy tablet is approved for people with obesity or those needing to reduce cardiovascular risk.Just In: “approval covers people with obesity and those needing to reduce cardiovascular risk.”
- SupportedThe TGA signed off on the Wegovy pill on Tuesday.Just In: “The Therapeutic Goods Administration (TGA) signed off on Tuesday on the Wegovy pill made by Danish pharmaceuticals giant Novo Nordisk.”
- SupportedBefore this approval, Australians with prescriptions could only use GLP-1 drugs as weekly injections.Just In: “Until now, Australians with prescriptions have only been able to use GLP-1 drugs in the form of weekly injections.”
- SupportedThe pill had been approved in the United States and Europe before the Australian decision.Just In: “The decision comes after the pill was approved in the United States and Europe, where demand surged once it hit the market.”
- SupportedDemand surged in the United States and Europe once the pill hit the market.Just In: “The decision comes after the pill was approved in the United States and Europe, where demand surged once it hit the market.”
- SupportedA TGA spokesperson said the pill was approved in four strengths: 1.5 mg, 4 mg, 9 mg and 25 mg.Just In: “A spokesperson for the TGA said the pill had been approved in four different strengths: 1.5 mg, 4 mg, 9 mg and 25 mg.”
- SupportedOne 25 mg semaglutide tablet acts the same as a 2.4 mg injection because oral absorption is less efficient.Just In: “One tablet containing 25 milligrams of semaglutide acts the same as a 2.4 milligram injection, due to the body absorbing active ingredients less efficiently when taken orally.”
- SupportedPatients will need a doctor's prescription.Just In: “Patients will need a doctor's prescription, and approval covers people with obesity and those needing to reduce cardiovascular risk.”
- SupportedUnder current rules, the PBS only subsidises weight-loss drugs for people with type 2 diabetes.Just In: “Under current rules, the Pharmaceutical Benefits Scheme (PBS) only subsidises weight loss drugs for people with type 2 diabetes.”
- SupportedThe TGA has yet to review the packaging and production processes to confirm they meet quality standards before release.Just In: “The TGA is yet to review the packaging and production processes to confirm they meet quality standards before the product can be released.”
- SupportedThe pill had three million prescriptions in its first five months of availability in the US this year.Just In: “Novo Nordisk has previously flagged Australia as a priority market for the pill, which saw three million prescriptions for the drug made in the first five months of its availability in the US this year.”
