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