Australia approves Wegovy tablets for the first time

The medicine regulator has approved Australia’s first oral GLP-1 weight-loss medication.

The Therapeutic Goods Administration (TGA) signed off on the Wegovy tablets on Tuesday.

Wegovy contains the active ingredient semaglutide and belongs to a family of drugs called GLP-1s.

Other GLP-1 medications include Ozempic, Saxenda and Mounjaro.

Until now, GLP-1 medications for weight loss have only been available as injectables.

Background

An estimated half a million Australians use GLP-1 medications, which mimic a hormone that regulates appetite and blood sugar.

They can slow ‘gastric emptying’, making patients feel fuller for longer.

GLP-1s are generally taken as daily or weekly injections and can cost several hundred dollars a month privately.

Common side effects include nausea, vomiting and diarrhoea.

A daily Wegovy tablet was approved in the U.S. last year and in the UK in June.

European pharmaceutical giant Novo Nordisk manufactures the treatment, as well as Ozempic.

TGA approval

The TGA first approved injectable Wegovy for weight loss and weight maintenance in 2022, but it did not reach Australian pharmacies until 2024.

On Tuesday, the regulator approved the tablet version.

In its decision summary, the TGA said Wegovy tablets can be prescribed for “chronic weight management” and to reduce the risk of “major adverse cardiovascular events”, such as a stroke or heart attack, in eligible adults.

The oral medication has been approved in four strengths: 1.5mg, 4mg, 9mg and 25mg.

Royal Australian College of GPs (RACGP) President Dr Michael Wright said the tablets “might be more attractive” to people who haven’t tried GLP-1s before.

However, he urged people to consult their GP before seeking a prescription, telling TDA that oral Wegovy is still a “serious medication”.

“You have to take it on an empty stomach, otherwise none of it gets absorbed, and there are still potential side effects from it that don’t change with it being oral,” Wright explained.

“If people are interested in losing weight, and particularly if they’re obese, there are a range of options, and this is just one,” he said.

Cost

It’s not yet clear how much Wegovy tablets will cost.

The injectable version is not currently listed on the PBS for weight loss, although Ozempic is subsidised for some patients with type 2 diabetes.

The Government is negotiating with Novo Nordisk to bring Wegovy onto the PBS for a limited group of eligible patients.

Wright did note that when oral Wegovy was rolled out in the U.S, it was “a bit cheaper than the injections”.

“So that’s another reason which might make it more attractive.”

Concerns

Butterfly Foundation Head of Communications and Engagement Mel Wilton said “the ease of delivery via a pill” was a concern.

“Irrespective of the type of weight-loss medication being administered, it’s essential that people’s mental health is looked after before, during and after taking these medications,” she told TDA.

Wilton called for “comprehensive medical, physical and psychological assessments” for all patients seeking GLP-1s, including a review of any history of disordered eating.

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