Exdensur (depemokimab)
Exdensur is approved as an add-on maintenance treatment for severe asthma in adults and adolescents with eosinophilic airways inflammation, and for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults, with limited response to systemic corticosteroids or surgery. Exdensur contains the active ingredient depemokimab.
Exdensur is approved as an add-on therapy for:
- Severe asthma – for maintenance treatment in adults and adolescents aged 12 years and older, with inflammation of the airways caused by eosinophils, a type of immune cell. It is intended for people whose asthma is poorly controlled on medium- to high-dose inhaled corticosteroids (ICS, or puffers), in addition to another asthma controller.
- Chronic rhinosinusitis with nasal polyps (CRSwNP) – for the treatment of adults with CRSwNP in addition to intranasal corticosteroids, when CRSwNP is poorly controlled by systemic corticosteroids or surgery.
Asthma is a common long-term inflammatory airway disease. Exdensur may be prescribed for severe asthma caused by ‘type 2 inflammation’, which is linked to high levels of eosinophils, a type of white blood cell involved in inflammation.
Chronic rhinosinusitis with nasal polyps (CRSwNP) is severe, long-term inflammation of the nose and sinuses that may occur with growths called polyps. These polyps can block or narrow the upper airways in the nose.
Exdensur is given as an injection under the skin (subcutaneous injection), usually in the thigh or abdomen (belly), once every 6 months. It can be given either by the patient, a trained caregiver or a healthcare professional.
In some people with severe asthma or CRSwNP, the body produces too many eosinophils. Eosinophils are a type of white blood cell involved in inflammation. A protein called interleukin-5 (IL-5) helps eosinophils grow, become active and survive. This can contribute to type 2 inflammation.
Exdensur is a long-acting monoclonal antibody. It is designed to attach to IL-5 and block its action. By blocking IL-5, depemokimab helps reduce the activity and survival of eosinophils. This may help reduce inflammation that can cause symptoms such as breathing problems, blocked nose and reduced sense of smell.
Exdensur may help prevent asthma attacks, also called exacerbations, particularly when asthma is not well controlled with existing treatment. Exdensur is not used to treat sudden asthma symptoms or an acute asthma attack.
In CRSwNP, Exdensur may help reduce symptoms such as a blocked nose, nasal discharge and reduced sense of smell. It may also help reduce the size of nasal polyps and may reduce the need for oral corticosteroid medicines or surgery.
The effectiveness and safety of Exdensur was studied in clinical trials involving adolescents (aged 12 years and older) and adults with asthma (SWIFT-1 and SWIFT-2 studies) and adults with CRSwNP (ANCHOR-1 and ANCHOR -2 studies).
In these 4 multicentre, global studies patients received either subcutaneous (SC) depemokimab or placebo (medicine with no active ingredients) once every 6 months.
Key findings from clinical studies
In the SWIFT-1 and SWIFT-2 studies, which included 762 adult and adolescent patients aged 12 years and older with asthma,
- the average annual rate of severe asthma attacks (exacerbations) was 0.5 in people who received Exdensur, compared with 1.1 in those who received placebo.
- the percentage of patients with asthma attacks (exacerbations) requiring hospitalisation and/or an Emergency Department visit was 3% for people receiving depemokimab, compared with 9% for patients receiving the placebo.
- health-related quality of life reported by asthma patients, assessed using the St George’s Respiratory Questionnaire (SGRQ) showed no difference between patients treated with Exdensur and those who received the placebo.
- health-related quality of life reported by asthma patients, assessed using the Asthma Control Questionnaire-5 (ACQ-5), showed no difference between patients treated with Exdensur and those who received placebo.
- lung function assessed using forced expiratory volume in one second (FEV1), showed no difference between patients treated with Exdensur and those who received placebo.
In the ANCHOR-1 and ANCHOR-2 studies, which included 528 patients with CRSwNP,
- Exdensur reduced the size of nasal polyps compared with placebo, based on nasal polyp scores assessed by endoscopy (a narrow tube with a lighted lens or small camera used to view inside the nose). By week 52, 43% of patients who received depemokimab had at least a 1-point improvement in nasal polyp score, compared with 24% of patients who received placebo.
- Perceived improvement in nasal obstruction was reported in 40% (110/272) of patients receiving depemokimab compared with 29% (75/256) of patients receiving placebo. Improvement was measured using self-assessed nasal obstruction VRS mean (average) scores.
The most common side effects (adverse or undesirable events) include skin itchiness and rash, headache, fatigue, and local injection site pain or swelling, with most events resolving in 2 days or less.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Exdensur and the medicine can be registered in Australia.
More detailed information on why the TGA approved Exdensur will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
Australian CMIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
Australian PIs can be accessed through the searchable TGA eBusiness Services or ARTG databases.
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.