Lilly's IL-17A Inhibitor Taltz Receives Fifth FDA Approval for Non-Radiographic Axial Spondyloarthritis

Eli Lilly and Company (Lilly) announced today that the U.S. FDA has approved an expanded indication for Taltz (ixekizumab), the company’s IL-17A antagonist, for the treatment of patients with active non-radiographic axial spondyloarthritis (nr-axSpA) who have objective signs of inflammation. The press release noted that this approval makes Taltz the first IL-17A antagonist approved by the FDA for nr-axSpA.

Axial spondyloarthritis (axSpA), which includes ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA), is a disease that primarily affects the sacroiliac joints and spine, leading to chronic inflammatory back pain and fatigue. It is estimated that 2.3 million people in the United States have axSpA, with approximately half of them having nr-axSpA. Patients with AS are characterized by structural damage to the sacroiliac joints visible on X-ray imaging, whereas patients with nr-axSpA show no clearly detectable structural damage on X-rays. Although these two subgroups share similar disease burdens and clinical features, approved biologic treatment options for patients with nr-axSpA are very limited, and the condition is often underdiagnosed.

Taltz is an IL-17A inhibitor developed by Eli Lilly and Company. The drug was first approved by the FDA in March 2016 for the treatment of moderate-to-severe plaque psoriasis. Subsequently, it also received approval for the treatment of adult patients with active psoriatic arthritis (PsA) and ankylosing spondylitis.

The safety and efficacy of Taltz were demonstrated in a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study that enrolled adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation. The primary endpoint was the proportion of patients achieving an Assessment of SpondyloArthritis international Society 40% improvement (ASAS40) response at Week 52. Trial results showed that the proportion of patients treated with Taltz who achieved the primary endpoint was superior to that of the placebo group: 30% of patients receiving Taltz (80 mg) every 4 weeks achieved an ASAS40 response, compared with 13% of those receiving placebo (P=0.0045). The key secondary endpoint was the ASAS40 response rate at Week 16; 35% of patients in the Taltz group achieved this endpoint, versus 19% in the placebo group (P<0.01).

“We recognize that many patients with this condition endure chronic inflammatory back pain and other inflammatory symptoms for years before being diagnosed, and we are pleased that these patients may find relief with Taltz,” said Mr. Patrik Jonsson, President of Lilly Biomedicines.

▽Follow [WuXi AppTecDe】WeChat Official Account