TGA registration of Exdensur (depemokimab) offers a new treatment option for Australians living with severe asthma

GSK Australia welcomes the Therapeutic Goods Administration (TGA) registration of Exdensur (depemokimab) as add-on maintenance treatment of severe asthma in patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller.¹  

Exdensur is also indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps inadequately controlled by systemic corticosteroids or surgery.¹  It is dosed twice per year for patients providing six months between these two doses of medication.¹  

Up to 200,000 Australians experience severe asthma.² Severe asthma is characterised by persistent daily symptoms and/or frequent flare ups, despite appropriate treatment.³ Severe eosinophilic asthma (SEA) is a subtype of severe asthma, where there are too many eosinophils (a type of white blood cell) in the blood and lungs, causing inflammation and an increased risk of asthma symptoms or attacks.² 

Chronic rhinosinusitis is a common chronic respiratory disease that affects up to one in 10 Australians.^4,5 An estimated 25-30% of people living with chronic rhinosinusitis also have nasal polyps (soft jelly-like tissue growths in the nose), termed chronic rhinosinusitis with nasal polyps (CRSwNP).^6,7 CRSwNP is associated with increased inflammation, including too many eosinophils in the blood and sinuses.⁸ 

According to Professor Jo Douglass, specialist physician and Professor of Medicine from the University of Melbourne, the registration of new treatment options for SEA and CRSwNP is a positive development for Australian patients living with persistent, recurring symptoms. 

“The treatment journey for people living with severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps can be long and complex. 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,” said Professor Douglass.  

“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.”  

The burden of asthma on the healthcare system is significant. Through 2023 and 2024 there were around 32,000 hospitalisations due to asthma.⁹ In 2024 and 2025 there were around 60,300 emergency department visits due to asthma.⁹ 

Julia Ovens, who lives with severe eosinophilic asthma, said many people do not understand what severe asthma is and that it can have a significant impact on much more than a person’s breathing. 

“Severe asthma is not ‘just asthma’. It’s a serious, chronic disease that affects people differently and can be life-threatening. It affects every aspect of your life – sleep, mental health, productivity and the ability to do normal every day things,” said Julia.  

“People don’t understand the battles that you experience with planning your day, every day. My severe asthma can be activated by the weather so I can’t leave home without first checking the pollen count and wind. Each day, I form a ‘battle plan’ so I can manage my day in the best way to avoid a trigger. Whether I am just going to work or the supermarket, I have to be prepared for anything,” she said.  

Exdensur works by targeting interleukin-5 (IL-5) to reduce the number of blood eosinophils and target the underlying eosinophilic inflammation associated with severe eosinophilic asthma and recurrent nasal polyps.¹ Exdensur is an anti-interleukin-5 (IL-5) monoclonal antibody administered once every six months for eligible Australians living with SEA and CRSwNP.¹  

Australians living with respiratory diseases, like severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps, experience debilitating symptoms that can impact their daily life.^9-12 People living with asthma are more likely to report a poor quality of life, especially those with severe or poorly controlled asthma.9 For those living with severe eosinophilic asthma, wheezing, coughing, shortness of breath and frequent, life-threatening attacks can impair a person’s ability to do everyday tasks like go to work, shopping or even walking short distances.^3,13,14 

Sebastian DiNatale, Country Medical Director, GSK Australia, said the TGA registration of Exdensur reflects GSK’s ongoing commitment to advancing innovation in respiratory medicine and to improve outcomes for people living with SEA and CRSwNP. 

“The registration of Exdensur demonstrates GSK’s long term commitment to respiratory disease and our ambition to help improve the lives of people living with complex inflammatory conditions. We are pleased that Exdensur has now been registered by the TGA for eligible patients in Australia,” said Sebastian.  

“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.” 

ENDS 

About GSK  
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at au.gsk.com. 

About severe eosinophilic asthma (SEA) 

Severe eosinophilic asthma is a type of severe asthma characterised by elevated eosinophils (a type of white blood cell) in the blood and lungs, causing inflammation and regular asthma symptoms or attacks.²  

About chronic rhinosinusitis with nasal polyps (CRSwNP) 

Chronic rhinosinusitis is a common chronic respiratory disease that affects up to one in 10 Australians.^4,5 

An estimated 25-30% of people living with chronic rhinosinusitis also have nasal polyps (soft jelly-like tissue growths in the nose), termed chronic rhinosinusitis with nasal polyps (CRSwNP).^6,7 

About Exdensur 

Exdensur is an anti–interleukin-5 (IL-5) monoclonal antibody that works by targeting interleukin-5 (IL-5) to reduce the number of blood eosinophils and target the underlying eosinophilic inflammation associated with severe eosinophilic asthma and recurrent nasal polyps.¹

Exdensur is indicated as add-on maintenance treatment of severe asthma in patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller, and as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps inadequately controlled by systemic corticosteroids or surgery.¹ 

Dose and method of administration¹  

Exdensur must be administered as a subcutaneous (SC) injection. Exdensur may be self-administered by adult or adolescent patients or administered by a caregiver using the pre-filled pen or pre-filled syringe if their healthcare professional determines that it is appropriate, and the patient or caregiver are trained in injection techniques.

For Severe Eosinophilic Asthma: In adults and adolescents 12 years and older, the recommended dose is 100 mg of Exdensur administered by subcutaneous (SC) injection once every 6 months. 

For CRSwNP: In adults 18 years and older, the recommended dose is 100 mg of Exdensur administered by subcutaneous (SC) injection once every 6 months 

The safety and efficacy of Exdensur have not been established in patients less than 12 years of age for Asthma and less than 18 years of age for CRSwNP 

Contraindications¹ 

No contraindications identified.  

Special warnings and precautions for use¹  

Hypersensitivity reactions: Acute and delayed systemic reactions, including hypersensitivity reactions (such as urticaria and pruritus), have occurred following administration of Exdensur. These reactions generally occur within hours of administration, but some had a delayed onset (i.e., days). In the event of a hypersensitivity reaction, clinical judgement must be used regarding re-administration of Exdensur.

Asthma-related adverse events or exacerbations: Exdensur must not be used to treat acute asthma symptoms or acute exacerbations. Asthma-related adverse events or exacerbations may occur during treatment with Exdensur. It is recommended that patients be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with Exdensur.

Reduction of corticosteroid dosage: Abrupt discontinuation of background medications (including systemic and inhaled corticosteroids) after initiation of Exdensur therapy is not recommended. Reductions in the dosages of background medications, if appropriate, must be gradual and performed under the supervision of a physician. 

Parasitic (helminth) infections: Eosinophils may be involved in the immunological response to some helminth infections. Patients with pre-existing helminth infections were excluded from participation in the clinical programme. Patients with pre-existing helminth infections should be treated for their infection prior to Exdensur therapy. If patients become infected while receiving treatment with Exdensur and do not respond to anti-helminth treatment, consider delaying administration of the next Exdensur dose until the infection resolves. 

Use in the elderly: There are no special precautions for use in the elderly. 

Paediatric use  

Asthma: The safety and efficacy of Exdensur have not been established in patients less than 12 years of age. 

Chronic Rhinosinusitis with Nasal Polyps: The safety and efficacy of Exdensur have not been established in patients less than 18 years of age. 

Effects on laboratory tests: No data available.  

Interactions with other medicines and other forms of interactions¹ 

Exdensur has a low potential for drug- drug interactions, based on its route of metabolism and mechanism of action. 

Adverse effects¹  

The most common adverse events (≥3%) were: in asthma, upper respiratory tract infection, rhinitis allergic, influenza, pharyngitis, arthralgia; in CRSwNP, nasopharyngitis, epistaxis and acute sinusitis. 

For information on GSK products or to report an adverse event involving a GSK product, please contact GSK Medical Information on 1800 033 109. GlaxoSmithKline Australia Pty Ltd. ABN 47 100 162 481. Melbourne, VIC. Trademarks are owned by or licensed to the GSK group of companies. 

PBS Information: Exdensur is currently not listed on the PBS. 

Consumer Medicines Information (CMI) can be accessed at www.gsk.com.au/exdensur

This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.  

Additional information 

In relation to this GSK media announcement, no honorarium was provided to Professor Jo Douglass. They have been briefed by GSK on the use of this product. 

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