Australian tech health providers say they are eager to sell an oral pill version of an Ozempic-style weight loss drug if it is approved for local use, after US authorities approved a new formulation overnight.
Local health firms Mosh, My Weight Loss Clinic and Eucalyptus – whose brands include Pilot and Juniper – all said they were now keenly awaiting Australia’s Therapeutic Goods Administration (TGA) to follow in the steps of its US counterpart, the Food and Drug Administration (FDA), which on Wednesday approved pharma company Eli Lilly’s new weight-loss pill.
The Lilly drug, orforglipron, which will be sold under the brand name Foundayo in the US, is a once-daily oral medication that targets the GLP-1 hormone. Patients taking the drug in a 72-week trial lost 12 per cent of their body weight, while in a previous 36-week trial, participants lost an average of 15 per cent of their body weight.
Lilly said it will begin selling Foundayo on April 6 through its direct-to-customer program at $US149 ($215) per month for the lowest dose, on par with a newly-offered pill from its rival Novo Nordisk, which pioneered Ozempic for diabetes and Wegovy for obesity. Novo Nordisk’s oral version of Wegovy was launched in the US in January to strong demand.
Dr Kieran Dang, chief medical officer at Mosh – which currently offers injectable Ozempic-style GLP-1 treatments – stressed the importance of waiting for TGA approval, which some in the industry expect some time this year, but was optimistic about how Lilly’s new pill could help patients.
“Many Australians have an aversion to needles, and options like Eli Lilly’s orforglipron could make these treatments far more accessible and easier to stick with long term,” Dang said on Thursday morning.
Dang also said that oral formulations offer other advantages such as not requiring cold-chain storage which boosts their shelf life, as well as being more affordable and easier to distribute to regional and remote Australians.
“Ultimately, Mosh is excited to be able to give our patients more choice,” Dang said.
Chris O’Donnell, chief executive of My Weight Loss Clinic, said he was “quite excited by” orforglipron, noting it may not be sold under its US name Foundayo once it gains approval and is sold in the Australian market.
O’Donnell said his company was in constant communication with Eli Lilly, as well as other drug manufacturers, but was particularly interested in orforglipron because it had less strict rules around intake compared to the oral Wegovy pill.
“We’re very interested in this, especially because it will work not just to give patients smaller tummies, but helping heart, liver and pancreas health, and helping people live without chronic diseases,” he said. “It’s about (waiting) for TGA approval, when that comes,” O’Donnell said.
Tim Doyle, co-founder and chief executive of Eucalyptus, on Thursday said “we will definitely be supplying both oral Wegovy and Foundayo when they reach our markets”.
After Wednesday’s FDA approval was announced, Lilly chief executive David Ricks told reporters his firm’s new pill would be suitable for patients seeking to lose weight or to maintain weight loss, and that the company has submitted the drug for approval in over 40 countries.
“We do expect approvals yet this year in several major markets. The Gulf states are one of those areas that tend to move a little quicker, so that would be one,” Ricks said.
Lilly’s pill can be taken at any time of day with or without food, compared with the Wegovy pill, which must be taken first thing in the morning and 30 minutes before any food, water or other medications.
“In the early innings of the launch, investors will be following closely to see if Foundayo’s lack of a food effect drives any difference in patient uptake,” BMO analyst Evan Seigerman said in a research note.
Shares of Lilly climbed 6 per cent on the news, while US-listed shares of Novo fell slightly after the approval announcement.
Most oral Wegovy patients are taking a GLP-1 for the first time, an indication that the pills can capture a share of the weight-loss market not served by injectables, said Novo Nordisk US operations executive Jamey Millar.
Millar said oral Wegovy patients have not had issues taking the pill according to instructions and that affordability and side effects are more significant factors for patients when choosing a drug.
Oral weight-loss drugs are not expected to fully replace injectables, which can deliver greater weight loss, but analysts estimate pills could capture around 20 per cent of the market by 2030.
The most commonly reported side effects of Lilly’s oral weight loss pill were mild-to-moderate gastrointestinal issues such as nausea and vomiting. Foundayo’s label also comes with a boxed warning – the FDA’s most serious label addition – advising of an increased risk of thyroid C-cell tumours. Novo’s oral and injectable Wegovy carry the same warning.
