Eli Lilly and Company (Lilly) has secured approval for its monoclonal antibody Taltz (ixekizumab) from the US Food and Drug Administration (FDA) for the treatment of active ankylosing spondylitis (AS) in adults.
The latest FDA approval is the third for Taltz with the first one coming in 2016 for the treatment of adults with moderate to severe plaque psoriasis. The second approval from the FDA came in December 2017 for active psoriatic arthritis in adults.
Ankylosing spondylitis, which is also called radiographic axial spondyloarthritis (r-axSpA), is a form of spondyloarthritis. The condition impacts the pelvic joints and spine, and can be distinguished by chronic inflammatory back pain, stiffness and impaired mobility and function.
Lilly US immunology vice president Rebecca Morison said: “Ankylosing spondylitis is a challenging disease that can cause severe back pain and if left untreated, can significantly impact patient mobility.
“We are excited to now offer Taltz as a treatment option for people in need of relief from the symptoms of AS. This approval further underscores Lilly’s commitment to helping people living with rheumatic diseases.”
Taltz injection 80mg/mL has been approved based on the efficacy and safety it showed in two randomised, double-blind, placebo-controlled phase 3 studies. Put together, the late-stage trials featured 657 adult patients with ankylosing spondylitis.
Results from the two phase 3 trials proved that patients subjected to Lilly’s monoclonal antibody delivered statistically significant and clinically meaningful improvements in signs and symptoms, compared to placebo, as defined by the Assessment of Spondyloarthritis International Society 40 (ASAS40) response.
Patients treated with the monoclonal antibody also showed statistically significant improvements across major secondary endpoints in the two studies.
Spondylitis Association of America CEO Cassie Shafer said: “Having new treatment options for the ankylosing spondylitis community is truly encouraging.
“The ongoing focus to help people impacted by the disease will hopefully lead us to an eventual cure.”
Taltz has been designed to bind selectively with interleukin 17A (IL-17A) cytokine and block the latter’s interaction with the IL-17 receptor. IL-17A, which is a naturally occurring cytokine, is considered to have a role in normal inflammatory and immune responses.
According to Lilly, Taltz prevents the release of pro-inflammatory cytokines and chemokines.