FDA approves supplemental BLA for Taltz for the treatment of active non-radiographic axial spondyloarthritis.- Eli Lilly

Eli Lilly and Company announced the FDA has approved a supplemental Biologics License Application (sBLA) for Taltz (ixekizumab) injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation. Another first-in-class milestone for the treatment, this approval makes Taltz the first IL-17A antagonist to be approved by the FDA for nr-axSpA. Axial spondyloarthritis (axSpA), which includes both AS and nr-axSpA, is a disease predominantly affecting the sacroiliac joints and the spine, resulting in chronic inflammatory back pain and fatigue. It is estimated that 2.3 million people in the U.S. have axSpA, and approximately half of those individuals live with nr-axSpA. For patients with AS, the disease is characterized by the presence of structural damage of the sacroiliac joints that appears on an X-ray, while patients with nr-axSpA do not have clearly detectable structural damage radiographically. These two patient subsets share a similar burden of disease and similar clinical features, but approved biologic treatment options for patients with nr-axSpA are much more limited and patients are often underdiagnosed.