Health Canada has approved TALTZ (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA)

TALTZ is now approved to treat patients across the axSpA spectrum, including ankylosing spondylitis and non-radiographic axSpA

TORONTO, Oct. 19, 2020 /CNW/ - On October 14, 2020, Health Canada approved TALTZ® for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have responded inadequately to, or are intolerant to conventional therapy.Another first-in-class milestone for the treatment, this approval makes TALTZ the first IL-17A inhibitor to be approved by Health Canada for nr-axSpA. This is the fourth 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 (AS) in 2020.

"People living with non-radiographic axial spondyloarthritis suffer through considerable pain and other symptoms of inflammation for as long as ten years before being accurately diagnosed. Limited treatment options exacerbate this challenge. Health Canada's approval of TALTZ for this indication offers potential relief to many Canadians living with this debilitating condition," says Dr. Doron Sagman, vice president, R&D and Medical Affairs, Eli Lilly Canada.

Axial spondyloarthritis (axSpA), which includes both AS and nr-axSpA, is a disease that predominantly affects the sacroiliac joints and the spine, which results in chronic inflammatory back pain and fatigue.2,3,4  For patients with AS, the disease is characterized by the presence of structural damage of the sacroiliac joints that appears on an X-ray, while patients with nr-axSpA do not have structural damage that is clearly detectable radiographically.6 These two patient subsets share a similar burden of disease and similar clinical features. However, approved biologic treatment options for patients with nr-axSpA are much more limited and patients are often underdiagnosed.4,5 Non-radiographic axial spondyloarthritis symptoms often first strike in late adolescence or early adulthood, often before the age of 40.7

This approval is based on the results from the Phase 3 COAST-X trial, which evaluated improvement in signs and symptoms of nr-axSpA as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response criteria compared to placebo. The ASAS40 response measures the improvement in signs and symptoms of the disease, such as pain, inflammation and function.

"In the COAST-X study, 35% of patients treated with TALTZ met the ASAS40 primary endpoint at Week 16 compared to 19% treated with placebo. In addition, more than twice as many people achieved ASAS40 when treated with TALTZ vs. placebo by week 52," says Dr. Proton Rahman, MD, FRCPC, Rheumatologist, St. John's, NL and COAST-X trial investigator. "These figures reiterate that TALTZ could be an effective treatment option for adults living with axial spondyloarthritis."

In COAST-X, the safety and efficacy of TALTZ was demonstrated in a Phase 3, multicenter, randomized, double-blind, placebo-controlled 52-week study of adult patients with active nr-axSpA with objective signs of inflammation. The primary endpoint of the study was the proportion of patients achieving ASAS40 at Week 16 (Canada, EU) and Week 52 (US). The proportion of TALTZ patients (n=96) achieving the primary endpoint of ASAS40 at Week 16 was superior to placebo (n=105), with 35% of patients treated with TALTZ 80 mg every four weeks achieving ASAS40 response compared to 19% of patients treated with placebo (p<0.05). A significantly higher proportion of patients treated with TALTZ achieved an ASAS40 response as early as Week 1 compared with placebo. The ASAS40 response at Week 52 was achieved by 30% of TALTZ patients, compared to 13% of placebo patients who achieved the same endpoint (p<0.01). The safety profile of TALTZ in patients with nr-axSpA was consistent with previous experience with TALTZ in other approved indications.

"We are pleased to learn that a new medication to treat non-radiographic axial spondyloarthritis has been approved by Health Canada," says Graeme Reed, Chair, Canadian Spondylitis Association. "Timely and equitable access to diverse and affordable treatment options are essential for patients living with this painful and debilitating condition." 

Other major secondary endpoints of the study included change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity (BASDAI), the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score, the proportion of patients achieving low disease activity (ASDAS <2.1), and change from baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) score in magnetic resonance imaging (MRI) of the sacroiliac joints. The major secondary endpoints were met, with TALTZ showing efficacy in reducing disease activity and sacroiliac joint inflammation, and in improving patient function and quality of life.

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 the COAST-X Study
COAST-X was a multicenter, randomized, double-blind, placebo-controlled 52-week study evaluating the efficacy and safety of TALTZ for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation. Patients were required to have an established diagnosis of nr-axSpA and active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Numeric Rating Scale (NRS) score ≥4 and a total back pain score ≥4 on a 0-10 scale at screening and baseline, and were required to have objective signs of inflammation by presence of sacroiliitis on MRI or presence of elevated CRP >5 mg/L.

About the TALTZ Program in axSpA
The COAST-X study is part of a clinical development program that aims to evaluate the efficacy and safety of TALTZ across various population subsets of patients with axSpA. The COAST program includes three registration studies, each of one year in duration: COAST-V in patients with ankylosing spondylitis (AS)/radiographic axSpA who are biologic-naive; COAST-W in patients with AS/radiographic axSpA who previously had an inadequate response or were intolerant to 1 or 2 tumor necrosis factor (TNF) inhibitors; and COAST-X in biologic-naive nr-axSpA patients with objective signs of inflammation. Patients could enroll into a long-term extension study (COAST-Y) after completing of any of these registration studies to receive TALTZ treatment for up to an additional two years.

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.

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 patients with non-radiographic axial spondyloarthritis 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.

REFERENCES

1 TALTZ Product Monograph, October 14, 2020.

2 Reveille JD, et al. Prevalence of axial spondylarthritis in the United States: Estimates from a cros

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