Health Canada Authorizes Lebrikizumab for Moderate to Severe Atopic Dermatitis in Patients 12 Years and Older

Health Canada has granted Eli Lilly's lebrikizumab (Ebglyss) authorization for moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and older.¹

The targeted IL-13 inhibitor will soon become available for those whose conditions are not adequately managed with topical prescription therapies or when such therapies are not advisable.

Approval is based on positive data from the ADvocate 1, ADvocate 2, and ADhere clinical trials. These studies collectively involved over 1,000 participants, including both adults and adolescents aged 12 to 18 who met the weight criteria of at least 40 kg and had moderate-to-severe AD.

ADvocate and ADhere

By week 16 of ADvocate 1 and 2, 43% and 33% of patients treated with lebrikizumab, respectively, achieved an Investigator's Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin.

Similarly, 59% and 52% of patients in the two studies achieved a 75% reduction in Eczema Area and Severity Index (EASI) scores, compared to 16% and 18% in the placebo groups.

For patients who responded to lebrikizumab at week 16 and continued treatment, a significant majority maintained their improvements through 52 weeks, with 76.9% and 81.7% sustaining their IGA and EASI 75 responses.

The ADhere trial evaluated the efficacy and safety of lebrikizumab in combination with topical corticosteroids (TCS), involving 211 patients with inadequately controlled symptoms despite using TCS with or without topical calcineurin inhibitors.

Results from the study further confirmed the efficacy of lebrikizumab in providing symptom relief and improving the quality of life for patients.

Patients treated with lebrikizumab reported considerable improvements in skin clearance and relief from itching within just 4 weeks of beginning treatment. The therapy has demonstrated long-lasting efficacy, maintaining its benefits for up to a year with a maintenance dose administered every 4 weeks.

The safety evaluation also showed that most treatment-emergent adverse events were mild to moderate in nature, with the most commonly reported adverse reactions including conjunctivitis, injection site reactions, dry eye, and herpes zoster.

Expert Reactions

Melinda Gooderham, MSc, MD, FRCPC, a dermatologist and Medical Director at SKiN Centre for Dermatology, emphasized the heterogeneity of AD and the need for diverse treatment options.

"The approval of [Ebglyss] lebrikizumab provides patients with much-needed treatment diversity," Gooderham said.¹ "Addressing the profound impact of severe itch, impact on sleep, and overall well-being underscores the urgency for innovative dermatological therapies and expanding treatment options."

Amanda Cresswell-Melville, Executive Director of the Eczema Society of Canada, echoed these sentiments.

"Atopic dermatitis can negatively impact quality of life for the sufferer and their whole family," Cresswell-Melville said.¹ "Beyond the uncomfortable physical symptoms, the condition can also impact many facets of life including sleep, self-esteem, and mental health."

Further Authorizations in Motion

In November 2023, the European Commission approved lebrikizumab for the treatment of moderate to severe AD in adult and adolescent patients 12 years and older.² Germany became the first country where lebrikizumab was available for prescription.

It was also approved in the United Kingdom in December 2023 and in Japan in January 2024.³

In the United States, the approval of lebrikizumab is highly anticipated following delays in the authorization process.

In October 2023, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Lilly regarding its Biologics License Application (BLA) for lebrikizumab.⁴ The decision stemmed from issues discovered during a multi-sponsor inspection of a third-party contract manufacturing organization involved in producing the monoclonal antibody drug substance for lebrikizumab. There were no concerns raised about the clinical data package, safety, or labeling of lebrikizumab.

Most recently, Lilly resubmitted its BLA in April 2024, with a decision from the FDA anticipated in the second half of this year.⁵

"We are encouraged by the strength of the clinical data for Ebglyss, and the hope it may provide to patients living with moderate-to-severe atopic dermatitis in Canada. Ebglyss will be an important treatment option for those living with this disease who continue to experience uncontrolled symptoms after topical use," said Ken Custer, General Manager of Lilly Canada, in a news release.¹ "Lilly is committed to providing solutions to some of the most challenging dermatological conditions, as we strive to put patients at the core of our work."

References

1. Health Canada authorizes Lilly's Ebglyss (lebrikizumab) for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older. News release. Cision; Eli Lilly Canada Inc. June 25, 2024. Accessed June 25, 2024. https://www.newswire.ca/news-releases/health-canada-authorizes-lilly-s-ebglyss-tm-lebrikizumab-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-in-adults-and-adolescents-12-years-and-older-833722064.html
2. Almirall. Almirall receives European Commission approval of Ebglyss (lebrikizumab) for moderate-to-severe atopic dermatitis. News release. November 17, 2023. Accessed June 25, 2024. https://www.almirall.com/newsroom/news/almirall-receives-european-commission-approval-of-ebglyss-lebrikizumab-for-moderate-to-severe-atopic-dermatitis
3. Keam SJ. Lebrikizumab: First approval. Drugs. 2024 Mar;84(3):347-353. doi: 10.1007/s40265-024-02000-z
4. US Food and Drug Administration issues complete response letter for lebrikizumab based on inspection findings at third-party manufacturer. News release. Eli Lilly. October 2, 2023. Accessed June 25, 2024. https://investor.lilly.com/news-releases/news-release-details/us-food-and-drug-administration-issues-complete-response-2
5. Lilly reports first-quarter 2024 financial results and raises full-year revenue guidance by $2 billion, highlights pipeline momentum. News release. Eli Lilly. April 30, 2024. Accessed June 25, 2024. https://investor.lilly.com/news-releases/news-release-details/lilly-reports-first-quarter-2024-financial-results-and-raises