Asia-Pacific Roundup: TGA warns against starting new patients on Ozempic

Australia’s Therapeutic Goods Administration (TGA) has advised physicians against starting new patients on the diabetes drug Ozempic after Novo Nordisk warned the supply disruption will continue throughout next year.

The active ingredient in Ozempic, semaglutide, is also used in Novo’s weight loss drug Wegovy. Demand for Wegovy, which is registered in Australia but has not come to market, is driving the off-label use of Ozempic as a weight loss medicine. The demand for semaglutide, which TGA attributes in part to social media, is causing a shortage of the GLP-1 receptor agonist and Eli Lilly’s Trulicity (dulaglutide), another GLP-1 receptor agonist.

Last week, Novo Nordisk told TGA that the supply of Ozempic will be limited for the rest of 2023 and throughout 2024. According to the company, demand has accelerated in recent months, particularly for the low dose (0.25/0.5 mg) version.

“This additional demand is caused mainly by a rapid increase in prescribing for off-label use,” TGA said. Demand for the low dose may reflect the dosing schedule for Wegovy. Patients spend the first 4 weeks on the 0.25 mg dose, before moving up to 0.5 mg for weeks 5-8. The dose rises to 1 mg, 1.7 mg and 2.4 mg over the following 3 months.

After consulting with clinical and patient groups represented on the Medicine Shortage Action Group, TGA has updated its advice to prescribers in Australia. The regulator is advising doctors against starting new patients on Ozempic “unless there are no suitable alternatives or there is a compelling clinical reason to do so.”

Similarly, TGA is asking doctors to consider whether patients who are already taking the Novo drug can be changed to an alternative treatment, in line with appropriate prescribing guidelines.

TGA and its advisors want to conserve supplies for “patients who are stabilized on Ozempic who have no other treatment options.” The regulator warned pharmacists that stockpiling and off-label use can cause demand to spike suddenly, affecting the “continuity of care for patients stabilized on Ozempic.”

“Limited” new supplies of Ozempic 0.25/0.5 mg will reach the Australian market this year, according to Novo, and there will be an “intermittent” supply of all other strengths through 2024.

TGA Notice

Singapore’s HSA starts monitoring potential link between GLP-1 agonists, suicidal thoughts

Singapore’s Health Sciences Authority (HSA) is reviewing a potential link between the use of
GLP-1 receptor agonists, eight of which are registered for use there, and suicidal thoughts. European regulators began reviewing the link earlier this year.

HSA has not yet received local adverse event reports of suicidal thoughts or self-harm associated with the class of medicines. However, with reviews by the European Medicines Agency and UK Medicines and Healthcare products Regulatory Agency underway, the Singapore authority is monitoring the situation.

HSA Notice

Australian government orders inquiry into COVID response to enhance preparedness

The Australian government has ordered an independent inquiry into the response to COVID-19 to learn lessons for future pandemics. Potential areas of focus include access to vaccines, therapies and personal protective equipment, suggesting the inquiry will cover the role TGA played in the response to the virus.

Australia took a different path through the pandemic than many countries, successfully locking down its borders to the extent that it had few cases throughout 2020 and the first half of 2021. The number of cases soared as the rules relaxed, and TGA gave emergency authorization to vaccines from Moderna, Pfizer and other companies weeks and months later than other regulatory agencies. An initial decision to ban at-home use of rapid antigen tests was another contentious aspect of TGA’s response.

The government has tasked three people with experience in public health, government and economic policy to review what happened. The Australian Prime Minister Anthony Albanese discussed the need for an inquiry.

“The COVID-19 pandemic has been the most significant global crisis that we have faced in decades. Its impacts are still being felt throughout Australia. This inquiry will look at the government’s responses and will give advice on what worked, what didn’t, and what we can do in the future to best protect Australians from the worst of any future events,” Albanese said in a statement.

The inquiry is scheduled to deliver its final report by 30 September 2024.

Press Release, More

New Zealand seeks feedback on upcoming meeting, including changes made in Australia

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is seeking feedback on the agenda for an upcoming meeting of its Medicines Classification Committee.

At the meeting, Medsafe plans to discuss three submissions for new classifications, including a filing for an asthma drug, Tezspire, developed by Amgen and AstraZeneca, and areas of potential harmonization with the Australian schedule.

Medsafe’s committee plans to discuss TGA’s move to limit the maximum pack size of immediate release paracetamol, as well as impose new restrictions on wrapped powders and sachets of granules. Australia will have smaller maximum pack sizes than New Zealand once it starts enforcing the changes in 2025. The agenda also covers Australia’s rescheduling of brimonidine, fexofenadine, melatonin and cetirizine.

Medsafe is accepting feedback on the agenda until 19 October. The meeting is scheduled for December.

Meeting Agenda

Other news:

Johnson & Johnson has voluntarily canceled its COVID-19 vaccine in Australia. The company canceled the viral vector vaccine from the Australian Register of Therapeutic Goods “due to no current or anticipated future demand,” according to TGA. J&J received provisional approval in Australia in June 2021 but never supplied the product, which was linked to blood clots, in the country. TGA Notice

Asia-Pacific Roundup: TGA warns against starting new patients on Ozempic

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