Australia's medicines regulator has approved the first GLP-1 weight loss drug in tablet form, clearing a daily Wegovy pill made by Danish pharmaceutical company Novo Nordisk for use in the country. The Therapeutic Goods Administration signed off on the product on Tuesday, according to ABC News & Headlines – Australian Broadcasting Corporation.
Until now, Australians holding a prescription could only access GLP-1 medications as weekly injections. The approval opens a needle-free option for patients, though the medicine will still require a doctor's prescription.
Why it matters
The decision gives Australian patients a second delivery method for a class of drugs that has drawn intense interest worldwide. It also positions Novo Nordisk in a market where rival Eli Lilly is waiting on the regulator's verdict for its own oral weight loss treatment, Orforglipro.
The TGA's clearance covers people living with obesity as well as those who need to lower their cardiovascular risk. Under existing rules, the Pharmaceutical Benefits Scheme subsidises weight loss medicines only for people with type 2 diabetes, so most patients would pay out of pocket.
Four strengths approved, price still unset
A TGA spokesperson told ABC News & Headlines – Australian Broadcasting Corporation that the pill has been approved in four strengths: 1.5 mg, 4 mg, 9 mg and 25 mg.
No Australian price guide has been set. In the United States, where the tablet is already on sale, it generally costs less than the injection even though each tablet carries a larger dose of semaglutide. A single 25 mg tablet is designed to work like a 2.4 mg injection, because the body absorbs the active ingredient less efficiently when it is swallowed rather than injected.
Novo Nordisk has previously identified Australia as a priority market. The company recorded three million prescriptions for the drug in the first five months it was available in the US this year, according to ABC News & Headlines – Australian Broadcasting Corporation.
The tablet had already been approved in the United States and Europe, where demand climbed sharply after launch.
Final checks before shelves
The TGA has not yet finished reviewing the packaging and manufacturing processes to confirm they meet required standards, the regulator said. That review must be completed before the product reaches the Australian market.
Separate reporting suggests the pill could be on sale in Australia before Christmas, though that timing depends on the outstanding checks.
For now, what to watch is the TGA's remaining assessment of packaging and production, the setting of an Australian price, and the regulator's pending decision on Eli Lilly's Orforglipro.