TGA approves first drug to treat obesity-linked sleep apnoea

The Therapeutic Goods Administration (TGA) has approved a new indication for Eli Lilly’s dual GLP-1/GIP receptor agonist, Mounjaro (tirzepatide), making it the first and only medicine to treat moderate-to-severe obstructive sleep apnoea (OSA) in adults living with obesity.

The dual GLP-1/GIP receptor agonist is now positioned to redefine the management of a condition that has traditionally relied on CPAP (continuous positive airway pressure) therapy – a treatment many patients struggle to maintain. Up to 50% of users abandon CPAP within the first year, highlighting a significant unmet need.

“This is a long-awaited development,” said Professor Ron Grunstein AM, Professor of Sleep Medicine at the University of Sydney and Head of the Sleep and Circadian Research Group at the Woolcock Institute of Medical Research, Macquarie University.

“For the first time, people with weight-related sleep apnoea [BMI ≥30] can be treated with a medicine that addresses the underlying cause of their condition. This will establish a new standard of care for this debilitating condition,” he added.

The new indication is supported by data from the global SURMOUNT-OSA trial program, which spanned 58 sites across nine countries, including Australia. In both randomised, double-blinded, placebo-controlled phase 3 trials, participants treated with Mounjaro over 52 weeks showed significant reductions in the apnoea-hypopnoea index (AHI).

Among patients on PAP therapy, the average baseline AHI of 49.5 events per hour dropped to 29.3 after Mounjaro treatment – a 41% reduction. In those not on PAP, the AHI fell by more than 50%, from 51.5 to 25.3 events per hour.

“The clinical benefits of Mounjaro in both PAP-treated and untreated patients were highly significant,” said Professor Grunstein, who was an Australian investigator in the trial. “Improvements in apnoea and hypopnoea are critically important to the health, wellbeing and quality of life of these patients.”

Beyond respiratory improvements, patients also achieved significant secondary outcomes, including weight loss and reduced hypoxic burden, a key marker linked to cardiovascular risk and mortality in OSA.

Obesity and obstructive sleep apnoea are inextricably linked, with an estimated 70% of OSA patients also classified as obese.

“Many patients with obstructive sleep apnoea do not adhere to treatment, which can exacerbate the severity of their condition,” Professor Grunstein said. “Being able to prescribe a medicine that is likely to be more acceptable to patients, and that tackles underlying and interlinked conditions, is a major step forward,” he added.

The regulatory green light for Mounjaro comes at a critical time. With 32% of Australians now living with obesity and the economic toll forecast to hit $87.7 billion by 2032, the pressure is mounting to find sustainable and effective interventions.

However, reimbursement remains a major policy hurdle. A recent Australian review has called for targeted Pharmaceutical Benefits Scheme (PBS) funding of anti-obesity therapies, particularly in high-risk patient cohorts such as pre‐transplant, pre‐cancer treatment or pre‐surgery.

Dr Kevin Lim, Associate Vice President Medical for Eli Lilly Australia, said “Our company is proud to deliver the first-ever medicine for obstructive sleep apnoea for people living with obesity, and remains committed to ensuring that patients receive affordable access to Mounjaro at the earliest opportunity.”

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