Health Canada has approved TALTZ? (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA)
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. |
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7?https://creakyjoints.org/education/what-is-non-radiographic-axial-spondyloarthritis/ |