Ozempic shortage won’t end this year, warns TGA

The national shortage of semaglutide (Ozempic) is showing no signs of abating and is now expected to continue into next year, endocrinologists are being warned.

The TGA says it has approved a new formulation of the GLP-1 receptor agonist – branded Wegovy – for chronic weight management, as an adjunct to a reduced-energy diet and increased physical activity when specific criteria are met.

However, the product is not yet being distributed in Australia and will not be a one-to-one replacement for Ozempic, it said in a statement last week.

“While Ozempic and Wegovy contain the same active ingredient, semaglutide, they have different approved indications and uses, as well as different dosages and devices,” it said (link here).

“As such, Ozempic and Wegovy are not interchangeable.”

It comes amid a surge in demand for Ozempic reportedly driven by a boom in off-label prescribing for weight-loss.

Back in May, Pharmacy Guild of Australia president Professor Trent Twomey told radio station 2GB there had been a rise in prescriptions by online weight loss clinics to patients wanting the drug as a hunger suppressant.

“These entrepreneurial GPs are popping up with apps that are issuing a script without them ever seeing a patient,” he said.

“There’s nothing illegal about it but it’s a bit immoral and this is what is driving up demand.”

Following a meeting with stakeholders earlier this month, the TGA said that due to the ongoing shortages, prescribers should consider alternatives before initiating Ozempic, given the “desired health outcomes may be tied to patients’ ability to secure supply in a timely manner”.

It also urged health professionals to continue to prioritise supply of the drug to patients with T2DM, where other diabetes medications were not suitable, to enable continuity of care.

“The [stakeholder] group recognised the challenges for people with type 2 diabetes affected by this shortage while acknowledging that obesity is a highly prevalent, serious, complex, and chronic disease that is challenging to manage,” it added.

“The group agreed that prescribers treating patients with either condition should be advised to strongly consider alternatives to semaglutide because of the current intermittent supply situation.”

Research backs semaglutide for weight loss and T2DM prevention

Meanwhile, research to be presented at the European Association for the Study of Diabetes (EASD) annual meeting in Stockholm next week appears likely to further boost demand for the drug.

For the study, a US team analysed the data from two trials of semaglutide, finding weekly 2.4mg injections more than halved the risk of developing T2DM in patients with overweight and obesity.

The trials were STEP4 and STEP1, in which 1961 participants with overweight or obesity received an injection of 2.4mg of semaglutide or a placebo weekly, for 68 weeks. STEP4 involved 803 participants with overweight or obesity. All received weekly injections of 2.4mg semaglutide for 20 weeks. They then either remained on semaglutide or were switched to placebo for the next 48 weeks.

Using Cardiometabolic Disease Staging, the researchers found that for STEP1 participants receiving semaglutide, 10-year risk scores for T2D decreased by 61% (from 18.2% at week 0 to 7.1% at week 68).

This compared to a 13% reduction in risk score for those given the placebo (17.8% at week 0 to 15.6% at week 68). Risk scores mirrored weight loss, which was 17%, on average, with semaglutide vs 3% with placebo.

The STEP4 participants also saw a significant decrease in risk scores, (from 20.6% at week 0 to 11.4% at week 20), further decreasing to 7.7% in those who continued receiving semaglutide, but rising above 15% in those switched to placebo.

The results showed semaglutide would be a ‘game changer’ in obesity medicine, said the study’s lead researcher Dr W Timothy Garvey, of the Department of Nutrition Sciences at the University of Alabama at Birmingham.

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