FDA approves Taltz to treat ankylosing spondylitis

Eli Lilly and Company announced that the FDA has approved Taltz (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). This is the third indication for Taltz, which was first approved by the FDA in March 2016 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and then approved by the FDA in December 2017 for the treatment of adults with active psoriatic arthritis.

Taltz may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (e.g. sulfasalazine), corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs) and/or analgesics. Taltz should not be used in patients with a previous serious hypersensitivity, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz may increase the risk of infection. Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity, inflammatory bowel disease, and immunizations.

AS is a type of spondyloarthritis that affects the pelvic joints and spine, and can be characterized by chronic inflammatory back pain, stiffness and impaired function and mobility. AS is estimated to impact approximately 1.6 million people in the U.S.