Regulatory Decision Summary for Ebglyss (lebrikizumab)

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.

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Type of Submission:

New Drug Submission (New Active Submission)

Decision Issued:

Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations

What was the purpose of this submission?

The purpose of this submission is to seek market authorization for Ebglyss (lebrikizumab) as systemic therapy for the treatment of adult patients and adolescent patients 12 years and older with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies.

After evaluation of the submitted data package, Health Canada authorized Ebglyss (lebrikizumab injection) for the following indication:

“Ebglyss (lebrikizumab injection) is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Ebglyss can be used with or without topical corticosteroids.”

Why was the decision issued?

Atopic dermatitis (AD), also known as atopic eczema, is a chronic, relapsing, inflammation of the skin that is characterized by intractable pruritus, extensive xerosis (abnormally dry and scaly skin), and skin lesions. The clinical manifestations of AD can lead to psychological and sociological sequelae that have a negative impact on patients’ lives.

The benefit of lebrikizumab in adults and adolescents (12 years of age and older who weigh at least 40 kg) with moderate-to-severe AD was demonstrated in three 52-week pivotal clinical studies assessing lebrikizumab used as monotherapy or in combination with topical corticosteroids (TCS). Treatment with lebrikizumab resulted in a higher proportion of patients achieving the co-primary efficacy endpoints compared to treatment with placebo. The difference was statistically significant and clinically meaningful. Clinically meaningful efficacy results were also demonstrated in adolescent subjects treated with lebrikizumab and these were consistent with the results observed in the adult population. Treatment benefit was further supported by the results for the key secondary endpoints. In some patients, lebrikizumab used as monotherapy or in combination with TCS was also shown to be efficacious beyond the initial 16-week treatment period for up to 52 weeks. The Produce Monograph (PM) indicated that continued therapy beyond 16 weeks should be carefully considered in a patient who does not show treatment benefit within this time period.

The safety profile of lebrikizumab in the target population was evaluated in 1,720 participants who were treated with either lebrikizumab or placebo in controlled and uncontrolled studies, including 891 participants who were exposed for at least 1 year. The most commonly reported adverse reactions in adolescents weighing at least 40 kg and adults are conjunctivitis, injection site reactions, conjunctivitis allergic, dry eye, and herpes zoster. The observed safety profile of lebrikizumab in adolescents (age 12 to <18 years of age who weigh ≥40 kg) was similar to the observed safety profile in adults with moderate-to-severe atopic dermatitis. The safety profile of lebrikizumab was similar whether administered as a monotherapy or with concomitant TCS. An increased rate in adverse events relating to the eye were reported, but these events were generally mild to moderate in severity. Lebrikizumab was generally well tolerated.

The recommended dose of Ebglyss is an initial dose of 500 mg (two 250 mg injections) injected subcutaneously at Week 0 and Week 2, followed by 250 mg (one injection) every two weeks until Week 16. View the Product Monograph for details.

Overall, based on the data evaluated as part of this submission, the benefit-risk profile of Ebglyss for the treatment of moderate-to-severe atopic dermatitis in adult and adolescent patients 12 years of age and older with a body weight of at least 40 kg, is considered favourable.

For further details about Ebglyss, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.

Date of Decision:



Eli Lilly Canada, Inc.

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Prescription Status:

Schedule D drug

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