Eli Lilly and Co. said the U.S. Food and Drug Administration granted additional approval to Taltz injection, this time to treat a type of arthritis that affects the pelvic joints and spine.
Taltz, or ixekizumab, is now approved for the treatment of adults with active ankylosing spondylitis, also known as radiographic axial spondyloarthritis. The disorder causes chronic inflammatory pain and stiffness in the neck and back impairing the mobility of the patients, and affects about 1.6 million people in the U.S., according to the Indianapolis-based drugmaker.
The approval is based on results from two phase 3 trials, Coast-V and Coast-W. The drug was better than placebo in improving signs and symptoms of ankylosing spondylitis after 16 weeks in both studies.
Taltz is already approved in the U.S. for adult patients with active psoriatic arthritis as well as moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Lilly plans to seek further approval of Taltz so it can be used to treat non radiographic axial spondyloarthritis which also affects the pelvic joints and the spine but is not visible on X-rays.
