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Ebglyss (lebrikizumab)
Australian Prescription Medicine Decision Summary
Sponsor
ARTGs
Device/Product name
Ebglyss
Active Ingredient
Lebrikizumab
Date of decision
Published
Submission type
Type A (New chemical entity)
ATC codes
D11AH: agents for dermatitis, excluding corticosteroids.
Decision
Approved
What was the decision based on
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.
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.
What steps were involved in the decision process
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
Date of entry onto ARTG
Dose forms
Ebglyss is a sterile, preservative-free, non-pyrogenic, clear to opalescent, colourless to slightly yellow to slightly brown solution, free of visible particles.
Strength
Each Ebglyss autoinjector (pre-filled pen) contains 250 mg/2 mL of lebrikizumab.
Other ingredients
Histidine
Glacial acetic acid
Sucrose
Polysorbate 20
Containers
Ebglyss is supplied in a 2 mL autoinjector (pre-filled pen) that delivers 250 mg/2 mL of lebrikizumab. The solution is contained in a clear glass syringe barrel with plunger. The plunger is not made with natural rubber latex.
Pack sizes
Ebglyss is available in a pack size of 1 single dose autoinjector (pre-filled pen).
Routes of administration
Subcutaneous injection.
Dosage
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.
Pregnancy category
Pregnancy Category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
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.
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.
What was approved
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.
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
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.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.