Health Canada Authorizes Lilly's Ebglyss™ (lebrikizumab) for the Treatment of Moderate-to-Severe Atopic Dermatitis in Adults and Adolescents 12 Years and Older

Ebglyss provides a new first-line biologic treatment for patients living with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable

Patients treated with Ebglyss experienced significant skin clearance and itch relief as early as 4 weeks  

Ebglyss delivers long-lasting efficacy for patients through one year of treatment with a maintenance dose of every 4 weeks

TORONTO, June 25, 2024 /CNW/ - Eli Lilly Canada Inc. announced today that Health Canada authorized Ebglyss™ (lebrikizumab), a targeted IL-13 inhibitor, 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 40kg, whose disease is not well controlled despite treatment with topical prescription therapies or when those therapies are not advisable.¹  

"As a physician, I recognize the heterogeneity of atopic dermatitis and the ongoing struggle to achieve long-term control," said Dr. Melinda Gooderham, Dermatologist and Medical Director at SKiN Centre for Dermatology. "The approval of [Ebglyss] lebrikizumab provides patients with much-needed treatment diversity. 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."

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

The authorization was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1,000 adults and adolescents (aged 12 to less than 18 years who weighed at least 40 kg) with moderate-to-severe atopic dermatitis who were unable to control their symptoms with topical medicines or other systemic treatments, and who were candidates for systemic therapies.

The co-primary endpoints from the ADvocate 1 and 2 monotherapy trials demonstrated that 43% and 33% of patients on Ebglyss achieved an IGA of 0 or 1, with a  reduction of at least 2-points  from baseline, as compared to 13% and 11% of patients on placebo, respectively, at 16 weeks. Similarly, 59% of patients in ADvocate 1, and 52% of patients in ADvocate 2, achieved  a 75% reduction in EASI score from baseline at week 16, compared to 16% and 18% of patients on placebo .^1,2 Of the patients from ADvocate 1 and 2 who were responders to Ebglyss at week 16 and  were re-randomized to 36 weeks of maintenance treatment with Ebglyss every 4 weeks, 76.9% and 81.7% maintained their IGA 0, 1 and EASI 75 response, respectively through 52 weeks.^1,4

Key secondary endpoints at week 16 from the ADvocate 1 and 2 trials showed that 46% and 40% of patients had an improvement of at least 4 points in the Pruritus NRS compared to 13% and 12% of patients on placebo, respectively. Similarly, 38% of patients in ADvocate1 and 31% of patients in ADvocate 2 achieved an EASI 90 response compared to 9% and 10% on placebo.^1,2

The safety evaluation of Ebglyss demonstrated that the majority of  treatment emergent adverse events were mild to moderate in severity.² The most commonly reported adverse reactions were conjunctivitis, injection site reactions, dry eye, and herpes zoster.¹

"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. "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."

About ADvocate 1 and 2

ADvocate 1 and 2 are 52-week randomized, double-blind, placebo-controlled, parallel-group, global, Phase 3 studies designed to evaluate Ebglyss as monotherapy in adults and adolescents (aged 12 to less than 18 years of age and weighing at least 40 kg) with moderate-to-severe atopic dermatitis.^2,4

During the 16-week treatment induction period, patients received Ebglyss 500 mg initially and at 2 weeks, followed by Ebglyss 250 mg or placebo every 2 weeks. In the maintenance period, patients with moderate-to-severe atopic dermatitis who achieved a clinical response (defined as IGA (0,1) with a 2-point reduction from baseline and/or EASI 75) after 16 weeks of Ebglyss treatment were re-randomized to receive Ebglyss every 2 weeks or 4 weeks or placebo for an additional 36 weeks. Patients who required rescue treatment during the induction period or who did not meet protocol-defined response criteria at 16 weeks received open-label Ebglyss every 2 weeks for an additional 36 weeks. ^2,4

About ADhere

ADhere is a 16-week randomized, double-blind, placebo-controlled, parallel-group, global, Phase 3 study to evaluate the efficacy and safety of Ebglyss in combination with TCS initiated in 211 adults and adolescents (aged 12 to less than 18 years of age and weighing at least 40 kg) with moderate-to-severe atopic dermatitis. In the study, patients' baseline atopic dermatitis symptoms were inadequately controlled by TCS with or without topical calcineurin inhibitors (TCI).¹⁰

About EBGLYSS

Ebglyss is a monoclonal antibody that targets IL-13 with high binding affinity and slow dissociation rate, to specifically prevent the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13.^1,7,8,11, IL-13 is a key cytokine in atopic dermatitis, driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening, and infection.^,9,12

Lilly has exclusive rights for development and commercialization of Ebglyss in Canada, the U.S., and the rest of the world outside Europe. Lilly's partner Almirall S.A. has licensed the rights to develop and commercialize Ebglyss for the treatment of dermatology indications, including atopic dermatitis, in Europe.

For more information about Ebglyss, please refer to the product monograph on Lilly.ca.

About Lilly

Lilly is a medicine company turning science into healing to make life better for people around the world. Lilly has been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Lilly's Canadian Affiliate, Eli Lilly Canada Inc. was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin.

Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.

To learn more about Lilly Canada, visit Lilly.ca, or follow us on LinkedIn. 

Ebglyss™ and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

References:

¹ Ebglyss. Product Monograph, Eli Lilly Canada Inc.,

² Silverberg J, et al. Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis. N Engl J Med. 2023 Mar 23;388(12):1080-1091. doi: 10.1056/NEJMoa2206714. Epub 2023 Mar 15. PMID: 36920778.

³ Data on File. Lilly USA, LLC. DOF-LK-US-0031.

⁴ Blauvelt A, et al. Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: 52-week results of two randomized double-blinded placebo-controlled phase III trials. B Journal Dermatol. 2023;188(6):740-748. doi:10.1093/bjd/ljad022

⁵ Data on File. Lilly USA, LLC. DOF-LK-US-0033.

⁶ Chiesa Fuxench ZC, et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. Journal of Investigative Dermatology. 2019;139, 583e590; doi:10.1016/j.jid.2018.08.028

⁷ Ultsch M, et al. Structural basis of signaling blockade by anti-IL-13 antibody lebrikizumab. J Mol Biol. 2013;425(8):1330-1339. doi:10.1016/j.jmb.2013.01.024

⁸ Okragly A, et al. Binding, neutralization and internalization of the interleukin-13 antibody, lebrikizumab. Dermatol Ther (Heidelb). Published online June 13, 2023. doi:10.1007/s13555-023-00947-7

⁹ Bieber T. Interleukin-13: targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54-62. doi:10.1111/all.13954

¹⁰ Simpson  EL, Gooderham  M, Wollenberg  A,  et al; ADhere Investigators.  Efficacy and safety of lebrikizumab in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis: a randomized clinical trial (ADhere).   JAMA Dermatol. 2023;159(2):182-191. doi:10.1001/jamadermatol.2022.5534_

¹¹ Ultsch M, et al. Structural basis of signaling blockade by anti-IL-13 antibody Lebrikizumab. J Mol Biol. 2013;425(8):1330-1339. doi:10.1016/j.jmb.2013.01.024

¹²Tsoi LC, et al. Atopic Dermatitis Is an IL-13-Dominant Disease with Greater Molecular Heterogeneity Compared to Psoriasis. J Invest Dermatol. 2019;139(7):1480-1489.

SOURCE Eli Lilly Canada Inc.

Media Contact: Jason Haug, Eli Lilly Canada Inc., [email protected], [phone]