Depemokimab has won TGA approval for severe eosinophilic asthma, expanding biologic treatment options for eligible Australians.
Australians with severe eosinophilic asthma could soon have access to the first anti-interleukin-5 biologic requiring just two doses a year after the Therapeutic Goods Administration registered depemokimab (Exdensur, GSK).
The biologic has been approved as add-on maintenance therapy for patients aged 12 years and older with severe asthma characterised by type 2 inflammation and an eosinophilic phenotype, whose disease remains uncontrolled despite medium- or high-dose inhaled corticosteroids plus another controller.
The approval also covers adults with chronic rhinosinusitis with nasal polyps that remains inadequately controlled despite systemic corticosteroids or surgery.
The decision adds another targeted biologic to Australia’s growing list of treatment options for severe asthma.
Existing anti-IL-5 therapies, including mepolizumab and reslizumab, and the anti-IL-5 receptor antibody benralizumab have become established options for patients with eosinophilic disease, reducing exacerbations and oral corticosteroid use in appropriately selected patients.
Depemokimab offers a different proposition: a sustained duration of action that allows dosing every six months.
Like other agents in the class, depemokimab targets the eosinophilic inflammation that underpins many cases of severe type 2 asthma. By binding interleukin-5, it reduces circulating eosinophils that contribute to airway inflammation and exacerbations.
The less frequent dosing schedule may prove attractive for patients requiring long-term biologic therapy, although clinicians are likely to weigh this against efficacy, safety, patient preference and funding arrangements when selecting treatment.
Up to 200,000 Australians are estimated to live with severe asthma, a condition associated with persistent symptoms, recurrent exacerbations and substantial healthcare utilisation despite maximal inhaled therapy.
Through 2023 and 2024 there were around 32,000 asthma-related hospitalisations nationally, while emergency departments recorded more than 60,000 asthma presentations during 2024 and 2025.
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Professor Jo Douglass, respiratory physician and Professor of Medicine at the University of Melbourne, said having another treatment option was welcome for patients with severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps, many of whom continue to experience symptoms despite multiple therapies.
“The treatment journey for people living with severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps can be long and complex,” she said.
“Many people require multiple treatments throughout their lives, yet may still face ongoing, potentially life-threatening breathing difficulties or exacerbations that can require emergency medical care.
“The registration of Exdensur provides an additional treatment option for eligible patients with severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps that can help reduce the burden of these diseases.”
Chronic rhinosinusitis with nasal polyps commonly coexists with severe eosinophilic asthma because both conditions are driven by type 2 inflammation. Around one in 10 Australians has chronic rhinosinusitis, with nasal polyps affecting approximately one-quarter to one-third of these patients.
According to the approved product information, the most common adverse events in asthma studies were upper respiratory tract infection, allergic rhinitis, influenza, pharyngitis and arthralgia.
The medicine is not indicated for acute asthma exacerbations, and background corticosteroids should not be stopped abruptly after treatment is initiated.
Depemokimab is not currently listed on the Pharmaceutical Benefits Scheme. Sebastian DiNatale, GSK Australia’s country medical director, said the drug’s TGA registration reflected the company’s ongoing commitment to advancing innovation in respiratory medicine and to improve outcomes for people living with SEA and CRSwNP.
“We are now 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,” he said.
