Eli Lilly announced Tuesday that a late-stage study of Taltz (ixekizumab) for the treatment of ankylosing spondylitis met the primary and all key secondary endpoints. The company noted that it plans to submit regulatory approvals for the drug pending results from other ongoing trials due later this year.
The COAST-V study included biologic disease-modifying anti-rheumatic drug-naïve patients with ankylosing spondylitis who received Taltz or placebo, with AbbVie's Humira (adalimumab) used as the active control arm.
Results showed that Taltz demonstrated a significant improvement in the signs and symptoms of ankylosing spondylitis as measured by the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response at 16 weeks, when compared to placebo. Eli Lilly indicated that the long-term efficacy of the therapy will be evaluated up to one year in the study.
The drugmaker added that detailed data from the late-stage study will be submitted for presentation at research conferences and publication in peer-reviewed journals later this year.
Taltz was previously cleared in the US, Canada and EU for the treatment of moderate-to-severe plaque psoriasis. The IL-17A inhibitor was later authorised by the FDA and European Commission for use in adults with active psoriatic arthritis.
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