Health care company Eli Lilly and Company (NYSE:LLY) revealed on Monday the receipt of approval from the US Food and Drug Administration (FDA) for Taltz (ixekizumab) injection in 80 mg/ml for the treatment of adults with active ankylosing spondylitis (AS), called radiographic axial spondyloarthritis (r-axSpA).
This is the third indication for Taltz, which was first approved by the US FDA for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy as well as for the treatment of adults with active psoriatic arthritis, said the company.
According to the company, 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.
The company added that the efficacy and safety of Taltz in AS was demonstrated in two randomised, 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, the company achieved the primary efficacy endpoint and demonstrated that patients treated with Taltz achieved statistically significant and clinically meaningful improvements in signs and symptoms, as defined by ASAS40 response, over placebo.
Additionally, the company said it will work with insurers, health systems and providers to ensure patients are able to access this treatment.
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