FDA expands approval of ixekizumab for nonradiographic axial spondyloarthritis
The FDA has expanded the approval of ixekizumab injection 80 mg/mL to include treatment of active nonradiographic axial spondyloarthritis in patients with objective signs of inflammation.
In a milestone approval, Eli Lilly’s ixekizumab (Taltz) has become the first IL-17A antagonist to be approved by the FDA for nonradiographic axSpA, allowing this drug to treat patients across the entire axSpA spectrum.
“We recognize that many patients living with this condition suffer from chronic inflammatory back pain and other symptoms of inflammation for years before being diagnosed, and we’re excited about the possibility of these patients finding relief with Taltz,” Patrik Jonsson, senior vice president and president of Lilly Bio-Medicines, said in a press release. “This approval reflects Lilly’s continued growth and commitment to supporting rheumatologists and people with autoimmune conditions, including nr-axSpA.”
The FDA based its decision on efficacy and safety results from the COAST-X study, a phase 3, multicenter, double-blind, placebo-controlled study of Taltz among adult patients with active nonradiographic axSpA (n = 303). Investigators randomly assigned patients to receive subcutaneous 80 mg Taltz every 4 weeks, every 2 weeks or placebo, with the primary endpoint of Assessment of Spondyloarthritis International Society 40 (ASAS40) response criteria compared with placebo.
According to researchers, the proportion of patients who received Taltz (n = 96) and achieved the primary endpoint was superior to placebo (n = 105), with 30% of patients treated with Taltz 80 mg every four weeks achieving ASAS40 response compared with 13% of patients treated with placebo at week 52 (P = .0045). A major secondary endpoint was ASAS40 response at Week 16 with 35% of Taltz patients compared with 19% of placebo patients who achieved that endpoint (P < .01).
“In the COAST-X study, Taltz provided relief to nr-axSpA patients living with debilitating symptoms such as chronic back pain and fatigue,” Atul Deodhar, MD, MRCP, of the Oregon Health and Science University, and clinical investigator for the COAST pivotal trial program said in the release. “The study results indicate that Taltz is safe and effective in patients suffering from this condition. Today’s FDA approval provides patients with a much-needed treatment option targeting IL-17A to improve the signs and symptoms of nr-axSpA.”
According to the FDA, the safety profiles observed in patients with nonradiographic axSpA were consistent with previous experience with Taltz in other approved indications. As Taltz may increase the risk for infection, it is advised that eligible patients for Taltz should receive pre-treatment evaluation for tuberculosis, hypersensitivity, inflammatory bowel disease and immunizations.
“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, CEO of the Spondylitis Association of America, said in the release. “This approval represents an important milestone in providing relief to patients where there has been a significant unmet need.”