Ebglyss (lebrikizumab)
Australian Prescription Medicine Decision Summary
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.
This submission was evaluated under the standard prescription medicines registration process.
The following table summarises the key steps and dates for this application:
Description | Date |
|---|---|
Submission dossier accepted and first round evaluation commenced | 1 May 2023 |
First round evaluation completed | 22 September 2023 |
Second round evaluation completed | 4 January 2023 |
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 1 March 2024 |
Advisory Committee meeting | April 2024 |
Registration decision (Outcome) | 16 May 2024 |
Completion of administrative activities and registration on ARTG | 29 May 2024 |
Number of working days from submission dossier acceptance to registration decision* | 190 |
*Statutory timeframe for standard submissions is 255 working days
Histidine
Glacial acetic acid
Sucrose
Polysorbate 20
The recommended dose of Ebglyss (lebrikizumab) is an initial dose of 500 mg (two 250 mg injections) injected subcutaneously at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16. For patients who achieve an adequate clinical response at Week 16, the maintenance dose is 250 mg every four weeks.
Consideration should be given to discontinuing treatment in patients who have shown no clinical response after 16 weeks of treatment.
Studies in animals have not shown evidence of an increased occurrence of fetal damage.
There are limited data on lebrikizumab use in pregnant women. Human IgG is known to cross the placental barrier, therefore, lebrikizumab may be transmitted from the mother to the developing fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown.
No embryofetal toxicity or malformations, or effects on morphological, functional, or immunological development in infants were seen in developmental toxicity studies in pregnant monkeys at maintenance subcutaneous doses up to 50 mg/kg per week during gestation, resulting in exposures up to 18 times the human exposure at the recommended dose.
Lebrikizumab crossed the placenta in monkeys and was quantifiable in infant serum up to the last assessment point
(6 months of age). No effects on morphological, functional, or immunological development were observed in infants. A higher risk of infections in infants exposed to lebrikizumab during the gestational period cannot be excluded.
As a precautionary measure, it is preferable to avoid the use of lebrikizumab during pregnancy.
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.
Ebglyss is to be included in the Black Triangle Scheme. The PI and CMI for Ebglyss must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product. The Ebglyss Risk Management Plan (RMP) as agreed with the TGA will be implemented in Australia. An obligatory component of RMPs is routine pharmacovigilance, which includes the submission of periodic safety update reports (PSURs).
All batches of EBGLYSS lebrikizumab supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD). When requested by the TGA, the Sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Product. An updated CPD should be provided when changes to finished product specifications and test methods are approved by the TGA.
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
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