New TGA-approved treatment offers hope for 200,000 Australians with severe asthma

The Therapeutic Goods Administration (TGA) has registered a new asthma treatment, Exdensur, which could transform the lives of approximately 200,000 Australians living with severe asthma. The treatment, administered via injection every six months, targets a protein that drives airway inflammation, offering a new option for patients who have struggled with conventional therapies.

For patients like Julia Ovens, a Melbourne resident with severe eosinophilic asthma, the condition is a constant battle. She must check pollen levels and wind conditions before leaving home, and always has a backup plan for potential flare-ups. “Living with severe asthma means constantly thinking ahead,” she said. “It can feel like having a full-time job managing your health before you’ve even started your actual job.”

What is Exdensur and how does it work?

Exdensur is the first treatment of its kind approved in Australia for patients aged 12 and older with severe asthma and chronic rhinosinusitis with nasal polyps. It works by targeting interleukin-5, a protein that stimulates the production of eosinophils, a type of white blood cell involved in inflammation. By lowering eosinophil levels, the drug reduces inflammation in the airways and sinuses.

Respiratory physician Professor Jo Douglass explained that the treatment “attacks” eosinophils and reduces the number of inflamed cells in the lungs. “The most prominent thing they do is reduce flare-ups or exacerbations of asthma,” she said. “They give people more stable asthma so they’re not so likely to get at times when their symptoms are out of control and they need to seek additional medication.”

Professor Douglass noted that many patients see improvements in lung function and symptoms within weeks, and some may notice benefits within the first 24 hours. “It just depends on the individual, but usually they work fairly quickly,” she added.

Why is this a significant development for Australian patients?

Severe asthma affects about 200,000 Australians, and one in 10 Australians experience chronic rhinosinusitis. Between 25 and 30 per cent of those develop nasal polyps, soft growths in the nose that can further complicate breathing. For patients like Ms Ovens, the condition is not merely inconvenient but can be life-threatening. “Severe asthma is not ‘just asthma’,” she said. “It’s a serious, chronic disease that affects people differently and can be life-threatening.”

The TGA registration is the first step toward making Exdensur widely accessible. The next stage involves listing the drug on the Pharmaceutical Benefits Scheme (PBS), which would allow patients to access it through their local GP rather than requiring a specialist visit. Biopharma company GSK Australia, which markets the treatment, welcomed the TGA’s decision. Country medical director Sebastian DiNatalie said the company is “focused on the next step and look forward to working with the Australian government to support equitable access for Australians who may benefit from this treatment.”

What does this mean for the future of asthma care in Australia?

The approval of Exdensur adds a new tool to the arsenal against severe asthma, which has historically been difficult to treat. Professor Douglass emphasized that the drug appears safe, with the TGA reviewing its safety profile and deeming it acceptable. “Overall, the drug seems very safe,” she said.

For patients like Ms Ovens, the treatment offers more than just symptom relief. “Any new treatment option that has the potential to improve the lives of people living with severe eosinophilic asthma is incredibly encouraging,” she said. “Severe asthma is a complex disease, and no single treatment works for everyone. That’s why it’s so important to continue developing new treatment options. Every additional therapy creates more opportunities to personalise care.”

Ms Ovens urged others to understand the seriousness of the condition. “Asthma is a life-threatening condition that requires constant management and affects every aspect of our lives,” she said. “At the end of the day, what everyone living with severe asthma wants is not sympathy or special treatment, just the freedom to breathe, to live fully and to stop thinking about their next breath.”

Frequently asked questions about Exdensur

Who is eligible for Exdensur?

Exdensur is approved for Australians aged 12 and older with severe asthma and chronic rhinosinusitis with nasal polyps.

How is Exdensur administered?

The treatment is given as an injection every six months, targeting the protein interleukin-5 to reduce airway inflammation.

When will Exdensur be available on the PBS?

GSK Australia is working with the Australian government to secure PBS listing, which would allow patients to access the drug through their GP. No timeline has been announced yet.

What are the main benefits of Exdensur?

Clinical evidence shows it reduces asthma flare-ups, improves lung function, and can provide symptom relief within weeks or even days for some patients.