Taltz® (ixekizumab) Approved by Health Canada for the Treatment of Pediatric Patients (six to less than 18 years of age) with Moderate- to Severe Plaque Psoriasis

TORONTO, April 2, 2021 /CNW/ - On March 29, 2021, Health Canada issued a Notice of Compliance for Taltz^® (ixekizumab) injection, 80 mg/mL, for the treatment of pediatric patients from six to less than 18 years of age with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. About one million Canadians, including children, live with psoriasis.¹

"In the Phase 3 pediatric study, Taltz met both co-primary endpoints: the proportion of patients achieving PASI 75 and the proportion of patients achieving a static Physician's Global Assessment of 0/1," says Perla Lansang, MD, assistant professor, Division of Dermatology, University of Toronto. "This approval from Health Canada is important news for Canadian children and adolescents who have psoriasis. This disease has such a big effect on the quality of life, not just of the patients, but their parents and caregivers as well.  The more options we have to effectively and safely treat the disease, the better we can serve our pediatric patients with psoriasis."

The efficacy, safety, and tolerability of Taltz in patients ages six to less than 18 years of age was demonstrated in a randomized, double-blind, placebo-controlled Phase 3 study that included 171 patients with moderate- to severe plaque psoriasis. The co-primary endpoints of the study were the proportion of patients achieving ≥ 75 per cent improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and a static Physician's Global Assessment of clear or almost clear skin (sPGA 0,1) at Week 12.

Patients were randomized to receive Taltz (20 mg for <25 kg, 40 mg for 25-50 kg or 80 mg for >50 kg through Week 12, with 40 mg, 80 mg or 160 mg starting doses, respectively) or placebo. At 12 weeks, the proportion of patients achieving the co-primary endpoints was superior to placebo with statistically significant difference (P<0.001):

• 89 per cent of patients treated with Taltz achieved PASI 75 compared to 25 per cent of patients treated with placebo.
• 81 per cent of patients treated with Taltz achieved sPGA 0,1 compared to 11 per cent of patients treated with placebo.

Taltz also met all major secondary endpoints in the study (P<0.001), which included the proportion of patients achieving PASI 90, sPGA (0) and PASI 100 at Week 12, and at least a four-point improvement in Itch Numeric Rating Scale (Itch NRS ≥4) among patients with baseline Itch NRS ≥4 at Week 12, as well as PASI 75 and sPGA 0,1 at Week 4.

"Understanding the ways psoriasis impacts the pediatric population and their families, and now being able to provide a treatment option, is a prime of example of the ways Lilly aims to discover medicines that make life better for people," says Dr. Doron Sagman, vice president, R&D and Medical Affairs, Eli Lilly Canada.

Overall, the safety profile observed in pediatric patients with plaque psoriasis treated with Taltz every four weeks is consistent with the safety profile in adult patients with plaque psoriasis, apart from the frequencies of conjunctivitis (3%), influenza (2%) and urticaria (2%). Additionally, in this clinical trial, Crohn's disease occurred at a greater frequency in the Taltz group (0.9%) than the placebo group (0%) during the 12-week, placebo-controlled period. Crohn's disease occurred in a total of four Taltz-treated subjects (2.0%) in the clinical trial. The Taltz safety profile has been studied across 13 clinical trials in adult subjects with plaque psoriasis, with over 5,000 patients receiving Taltz, with a total exposure of over 17,000 patient-years.

This is the fifth indication for Taltz, which was first approved by Health Canada for moderate- to severe plaque psoriasis in 2016, psoriatic arthritis in 2018, and ankylosing spondylitis and non-radiographic axial spondyloarthritis in 2020.

About Taltz^®
Taltz^® (ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.² IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Taltz inhibits the release of pro-inflammatory cytokines and chemokines.² Consult the Taltz Product Monograph for more information: http://pi.lilly.com/ca/taltz-ca-pm.pdf

About the Phase 3 Pediatric Study
The Health Canada approval of Taltz in pediatric patients with moderate- to severe plaque psoriasis was based on a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of Taltz in patients from 6 to under 18 years of age. The co-primary endpoints of the study were the proportion of patients achieving a 75 per cent improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and a static Physician's Global Assessment of clear or almost clear skin (sPGA 0,1) at Week 12. Key secondary endpoints included the proportion of patients achieving PASI 90, sPGA 0 and PASI 100 at Week 12, and at least a four-point improvement in Itch numeric rating scale (Itch NRS ≥4) among patients with baseline Itch NRS ≥4 at Week 12, as well as PASI 75 and sPGA 0,1 at Week 4.

About Lilly in Dermatology
By following the science through uncharted territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

About Eli Lilly Canada
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada 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. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.

For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA and @LillyMedicalCA.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz (ixekizumab) as a treatment for pediatric patients with moderate- to severe plaque psoriasis and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that Taltz will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

SOURCE Eli Lilly Canada Inc.