All doses of the drug will be in short supply until late next year, due to high demand.
The TGA has warned of an expected shortage of diabetes drug Mounjaro lasting well into next year.
“Eli Lilly has informed us that availability of all strengths of Mounjaro (tirzepatide) will be limited until 31 August 2024 due to unexpected high demand,” the Australian regulator said in a statement.
Manufacturer Eli Lilly said supply issues were due to “larger than expected demand, and is not related to any safety, efficacy or quality issue for Mounjaro”.
Current Mounjaro stock availability varies by dose:
- 2.5mg and 5mg are unavailable and expect limited availability from 15 December 2023
- 7.5mg is unavailable and expect limited availability from 15 February 2024
- 10mg is unavailable and expect limited availability from 15 January 2024
- 12.5mg and 15mg Mounjaro doses have limited availability.
Like Ozempic (semaglutide, Novo Nordisk), Mounjaro is a glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist used for the management of type 2 diabetes. But the once-weekly injection has also gained global popularity as an off-label therapy for weight loss.
Tirzepatide was approved for type 2 diabetes by the TGA in December 2022, but an application for PBS subsidisation was rejected earlier this year.
Without government funding, consumers can expect to pay hundreds of dollars per month depending on the dose.
“We recommend that patients who are unable to fill their script for the correct strength of Mounjaro in time for their next dose should contact their doctor immediately to have their treatment plan reassessed,” the TGA advised.
Ozempic is also expected to be in shortage throughout 2024, with the regulator asking prescribers not to initiate new patients on Ozempic “unless there are no suitable alternatives or there is a compelling clinical reason to do so”.
“For patients who are already prescribed Ozempic, consider if they can be changed to an alternative (by consulting appropriate prescribing guidelines) as continuous supply cannot be guaranteed,” it said.
Mounjaro may be more effective than Ozempic at achieving weight loss, according to a recent preprint comparison study on 18,000 people.
After three months on the treatment, Mounjaro users lost 6% and Ozempic users lost 4% of their body weight. At 12 months this had jumped to 15% and 8%.
Around half of the participants had diabetes, and those individuals lost less weight on average than users without diabetes, the electronic health record data showed.
