First Medicine for Sleep Apnoea - Mounjaro Now Indicated by TGA for Common Sleep Disorder

A medicine widely used to treat type 2 diabetes and obesity can now also be used for obstructive sleep apnoea, a debilitating sleep disorder affecting hundreds of thousands of Australians.

The Therapeutic Goods Administration (TGA) today expanded the usage of Mounjaro (tirzepatide) to include the treatment of moderate-to-severe obstructive sleep apnoea in adults living with obesity.

This makes Mounjaro the first and only medicine for obstructive sleep apnoea in Australia.

The most prevalent of all sleep disorders, obstructive sleep apnoea affects around 780,000 Australian adults. It occurs when a person's upper airway becomes blocked, causing breathing to be repeatedly interrupted during sleep. The condition is a known risk factor for life-threatening heart disease and can seriously impact physical, mental and social functioning. 

Professor Brendon Yee, Respiratory and Sleep Physician at the Woolcock Institute of Medical Research, said the news was a "long-awaited development" in the field of sleep medicine.

"For the first time, people with weight-related obstructive sleep apnoea can be treated with a medicine that addresses the underlying cause of their condition. This marks a significant milestone in the treatment of this debilitating sleep disorder," said Professor Yee, who was involved in a major clinical trial of Mounjaro for obstructive sleep apnoea.

"Obstructive sleep apnoea can affect anyone, and obesity is the single greatest cause of the condition. At least 70 per cent of people living with obstructive sleep apnoea also live with obesity," he said.

Mounjaro is a dual-acting therapy which works by mimicking two natural hormones, (glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]). Its role in the treatment of obstructive sleep apnoea is by virtue of weight reduction, easing pressure on the chest and abdomen and reducing excess fat around the neck and throat.

"We know that the most effective way to treat most obstructive sleep apnoea is to treat the underlying excess weight, which in turn reduces the risk of a host of complications, from type 2 diabetes to heart disease," said Professor Yee.

"Patients often experience a vicious cycle of excessive weight and sleep apnoea, with each condition exacerbating the other," he said.

Obesity contributes to the development and severity of obstructive sleep apnoea in several ways. Most commonly this involves excess weight obstructing the neck and tongue so that the airway is narrowed and prone to collapse during sleep, or through increased abdominal girth compressing the chest wall and reducing the ability of the lungs to expand and contract.

"Obstructive sleep apnoea is incredibly pervasive – not only does it affect every aspect of a patient's wellbeing and quality of life, it significantly increases the risk of developing other health conditions," said Professor Yee.

Current treatment options for obstructive sleep apnoea are limited. Treatment usually involves the use of a continuous positive airway pressure (CPAP) machine when attempting sleep. If that does not provide sufficient relief, surgery may be required.

Obstructive sleep apnoea is associated with nearly 60,000 hospitalisations annually in Australia. It increases the risk of serious health complications including heart disease, stroke, type 2 diabetes and depression, as well as motor vehicle and workplace accidents.

According to Dr Moira Junge, CEO of the Sleep Health Foundation, many people with obstructive sleep apnoea go without treatment due to a lack of effective medicines.

"Untreated sleep apnoea places people at increased risk of significant complications, from heart disease to dementia. Too many people with obstructive sleep apnoea suffer in silence, so a new treatment option will be warmly welcomed by patients and doctors," she said.

Dr Kevin Lim, Associate Vice President Medical for Eli Lilly Australia, said that the new TGA indication marked an important milestone for the treatment of obstructive sleep apnoea.

"Lilly continues to invest significantly in research and innovation to find solutions to some of the greatest unmet needs in medicine, and obstructive sleep apnoea has been one of these areas.

"Our company is proud to deliver the first-ever pharmaceutical treatment for obstructive sleep apnoea for people living with obesity, and we remain committed to ensuring that patients receive affordable access to Mounjaro at the earliest opportunity," said Dr Lim.

Lilly introduced the multi-use Mounjaro KwikPen in 2024 to resolve previous supply issues in Australia. All doses of Mounjaro KwikPen remain available, with Lilly committed to ongoing replenishment of all doses. The company has made significant investments and expansions in manufacturing around the world, allowing for dramatic increases in capacity.


About Mounjaro (tirzepatide)

Mounjaro is available on private prescription, not through the Pharmaceutical Benefits Scheme (PBS), for the treatment of:

• Moderate-to-severe obstructive sleep apnoea in adults living with obesity (BMI ≥30);
• Insufficiently controlled type 2 diabetes in addition to diet and exercise;
• Chronic weight management in people living with obesity (BMI ≥30) or overweight (BMI ≥27) with a related health condition (such as high blood pressure, high cholesterol, heart disease, prediabetes or sleep apnoea).

As with all medicines, Mounjaro may be associated with some side effects. The most commonly occurring side effects can include an upset stomach, injection site-related side effects, and low blood sugar. 

Mounjaro should not be used for the treatment of diabetic ketoacidosis, or by people with type 1 diabetes, children or adolescents under 18 years of age, pregnant women, or those who are allergic to any of the medicine's ingredients.

For further information, please review the Mounjaro KwikPen^® Consumer Medicine Information.

https://rss.medsinfo.com.au/ly/cmi.cfm?product=lycmounk10824