The Therapeutic Goods Administration has approved Exdensur, a new maintenance treatment for Australians aged over 12 living with severe asthma and chronic rhinosinusitis with nasal polyps, according to announcements from the regulatory body and drug manufacturer GSK Australia. The therapy targets approximately 200,000 Australians affected by severe asthma symptoms, offering a newly registered clinical option to reduce airway inflammation and lower the frequency of debilitating flare-ups.
Therapeutic Goods Administration Approval Details
Exdensur operates by targeting interleukin-5, a specific protein that prompts the body to produce white blood cells known as eosinophils, according to clinical data outlined by respiratory physician Jo Douglass. By lowering eosinophil counts, the six-monthly injectable treatment reduces inflammation within the lungs and sinuses. Professor Douglass stated that the primary clinical benefit involves cutting down asthma exacerbations and delivering more stable respiratory function for patients who otherwise face severe, hard-to-manage symptoms.
While the Therapeutic Goods Administration has cleared the medication’s safety profile and granted formal registration, the drug is not yet available through the Pharmaceutical Benefits Scheme. Patients currently must consult a specialist to receive prescriptions. Sebastian DiNatalie, country medical director at GSK Australia, noted that the company is collaborating with the Australian government to pursue equitable public access following the regulatory milestone.
Did You Know? Between 25 and 30 percent of Australians who experience chronic rhinosinusitis also develop nasal polyps, which are soft and jelly-like growths in the nose that frequently complicate severe asthma management.
Patient Impact and Daily Management
For Melbourne resident Julia Ovens, managing severe eosinophilic asthma requires constant daily vigilance well before starting regular work duties. Ms Ovens described checking wind conditions and pollen levels, avoiding known triggers, and maintaining backup plans to handle potential shortness of breath and chest tightness. She noted that the chronic condition demands meticulous tracking of symptoms to prevent life-threatening flare-ups.
Ms Ovens emphasized that severe asthma extends far beyond standard respiratory irritation, characterizing it as a complex disease that impacts every facet of daily life. Commenting on the regulatory approval, she stated that additional therapy choices create vital opportunities to personalize patient care and reduce the heavy burden of constant health monitoring.
Frequently Asked Questions
Who is eligible for the newly approved Exdensur treatment?
The Therapeutic Goods Administration approved the maintenance treatment for individuals aged over 12 diagnosed with severe asthma and chronic rhinosinusitis with nasal polyps.
How is the medication administered?
The treatment is given via injection every six months to target interleukin-5 and lower eosinophil levels, according to clinical explanations provided by Professor Jo Douglass.
Is the treatment currently available on the PBS?
Patients currently need a specialist consultation for access.
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