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Ebglyss (lebrikizumab)
Australian Prescription Medicine Decision Summary
Published
Product name
Ebglyss
Active ingredient
Lebrikizumab
Submission type
Type A (New chemical entity)
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Ebglyss was approved for the treatment of adult and adolescent patients (12 years of age and older) with moderate to severe atopic dermatitis who are candidates for systemic therapy.
How this medicine works
Ebglyss (lebrikizumab) is an immunoglobulin G4 (IgG4) monoclonal antibody that binds with high affinity to interleukin (IL)-13, blocking the downstream effects of IL-13 with high selectivity. Blockade of IL-13 signalling is expected to be of benefit in atopic dermatitis in which IL-13 is a key contributor to disease pathogenesis. In lebrikizumab clinical studies, lebrikizumab reduced the levels of several serum inflammatory biomarkers, providing indirect evidence of inhibition of the IL-13 pathway by lebrikizumab.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology studies conducted in animal models), clinical (pharmacology, safety and efficacy trials in humans) and risk management plan information submitted by the sponsor.
The efficacy and safety of lebrikizumab in adult and adolescent patients with moderate-to-severe atopic dermatitis was evaluated in three pivotal Phase 3 studies, including two monotherapy studies and one in combination with topical corticosteroids, as well as two supportive Phase 3 studies.
The benefit-risk profile of Ebglyss (lebrikizumab) was considered favourable for the therapeutic use approved.
Consumer Medicine Information (CMI)
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.
The Australian CMIs can be accessed through the ARTG details hyperlink below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlink below.
Sponsor
Other resources
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.