Health Canada has approved TALTZ® (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)

Eli Lilly Canada announced today that Health Canada approved TALTZ ® (ixekizumab) on February 4, 2020, for the treatment of adult patients with active ankylosing spondylitis (AS), which is also known as radiographic axial spondyloarthritis (r-axSpA), who have responded inadequately to, or are intolerant to, conventional therapy. This is the third indication for TALTZ, which was first approved by Health Canada for moderate- to severe plaque psoriasis and psoriatic arthritis in 2016 and 2018, respectively.

“People living with ankylosing spondylitis deal with a considerable amount of pain and anxiety. If left untreated, it can severely affect their mobility and mental wellbeing,” says Dr. Doron Sagman, Vice President, R&D and Medical Affairs, Eli Lilly Canada. “We are very pleased that TALTZ is now approved for the treatment of AS in Canada.”

AS is a chronic inflammatory disease that often starts at the base of the spine in the sacroiliac joints around the pelvis, and can spread upwards to other parts of the spine; it is estimated to affect 300,000 Canadians. 1

“We are pleased to learn that a new medication to treat ankylosing spondylitis has been approved by Health Canada. Timely and equitable access to diverse treatment options are essential for patients living with this painful and debilitating condition,” says Graeme Reed, interim President, Canadian Spondylitis Association.

The efficacy and safety of TALTZ in AS was demonstrated in two randomized, double-blind, placebo-controlled Phase 3 studies that included 657 adult patients with active AS: COAST-V in patients who are biologic disease-modifying antirheumatic drug (bDMARD)-naïve, and COAST-W in patients who previously had an inadequate response or were intolerant to tumor necrosis factor (TNF) inhibitors.

In both studies 2 , the primary efficacy endpoint was the proportion of patients at 16 weeks achieving Assessment of Spondyloarthritis International Society 40 (ASAS40) response compared to placebo. ASAS40 measures disease signs and symptoms such as pain, inflammation and function. The COAST clinical trial program includes the first and only registration trials in AS to achieve ASAS40 response at 16 weeks as a primary endpoint.

Results from both studies demonstrated that patients treated with TALTZ achieved statistically significant and clinically meaningful improvements in signs and symptoms, as defined by ASAS40 response, compared to placebo. At 16 weeks, patients achieved ASAS40 at the following response rates:

COAST-V: 48% of patients treated with TALTZ every four weeks versus 18% of patients treated with placebo (p<0.001)

COAST-W: 25% of patients treated with TALTZ every four weeks versus 13% of patients treated with placebo (p<0.05)

Additionally, patients treated with TALTZ demonstrated statistically significant improvements in key secondary endpoints in both studies, including the proportion of patients at 16 weeks achieving ASAS20 at the following response rates:

COAST-V: 64% of patients treated with TALTZ every four weeks versus 40% of patients treated with placebo (p<0.01)

COAST-W: 48% of patients treated with TALTZ every four weeks versus 30% of patients treated with placebo (p<0.01)

“TALTZ achieved a significant improvement over placebo in ASAS40 at Week 16, which is a more stringent endpoint than the commonly used ASAS20,” says Dr. Proton Rahman, MD, FRCPC, Rheumatologist, St. John’s NL and COAST-W study investigator. “Health Canada’s approval is helpful for physicians who are looking for alternative treatment options and significant for our patients with AS.”

Overall, the safety profile observed in patients with AS who were treated with TALTZ is consistent with the safety profile in patients with psoriasis.

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. 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.

About Lilly in Rheumatology Lilly in rheumatology aims to create a brighter future for people with debilitating rheumatologic diseases through innovative discoveries and patient-centered solutions.

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 .

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Media Contact: Samira Rehman Rehman_Samira@lilly.com 647-617-1994

REFERENCES 1 Arthritis Society. https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/ankylosing-spondylitis 2 TALTZ Product Monograph .