The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for ixekizumab (Taltz) injection 80 mg/mL for the treatment of patients suffering from objective signs of inflammation due to active non-radiographic axial spondyloarthritis (nr-axSpA).
The indication makes the interleukin-17A (IL17A) inhibitor the first of its class to be approved for nr-axSpA.
The FDA based its approval on findings from the phase 3 COAST-X trial, in which improved signs and symptoms of the inflammatory disease were gauged by the proportion of nr-axSpA patients to achieve Assessment of Spondyloarthritis International Society 40 (ASAS40) response criteria, versus those given placebo.
The ASAS40 criteria measures signs and symptoms including pain, inflammation, and function in patients.
Ixekizumab demonstrated efficacy and safety in the multicenter, randomized, double-blind, placebo-controlled, 52-week study. Investigators observed that 30% of all patients treated with 80 mg therapy every 4 weeks achieved ASAS40 response, versus just 13% of placebo-treated patients, at week 52 (P
Another 35% of ixekizumab-treated patients had achieved the endpoint at week 16, versus 19% of placebo patients (P
The safety profile of ixekizumab in patients with nr-axSpA was consistent with that observed in previous indications. Investigators stressed the therapy not be administered to patients with previous serious hypersensitivity reaction including anaphylaxis.
Axial spondyloarthritis (axSpA), which includes nr-axSpA, predominantly affects patients’ sacroiliac joints and spines, driving chronic inflammatory back pain and fatigue. An estimated 2.3 million people in the US have axSpA, and about half of those individuals have nr-axSpA.
This patient population is burdened with chronic inflammatory symptoms and pains, but lacks marketed biologic therapies currently available in other inflammatory indications.
"There are limited treatment options that can address both AS and nr-axSpA symptoms, and people living with these conditions are often underdiagnosed and undertreated," Cassie Shafer, chief executive officer of the Spondylitis Association of America, said in a statement
. "This approval represents an important milestone in providing relief to patients where there has been a significant unmet need."
Ixekizumab was previously approved for 4 other indications, including moderate to severe plaque psoriasis in adult patients, active psoriatic arthritis in adult patients, active ankylosing spondylitis in adults, and moderate to severe plaque psoriasis in pediatric patients aged 6 years and older.