The new approval represents the third time the FDA approved the injection treatments for adults.
The US Food and Drug Administration (FDA) has approved ixekizumab (Taltz) injection 80 mg/ml to treat adults with active ankylosing spondylitis (AS).
The approval represents the third indication for Eli Lilly and Company’s Taltz, which was first approved in 2016 to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy and phototherapy. The FDA then approved the drug in 2017 to treat adults with active psoriatic arthritis.
"Ankylosing spondylitis is a challenging disease that can cause severe back pain and if left untreated, can significantly impact patient mobility," Rebecca Morison, vice president, U.S. Immunology at Lilly, said in a statement. "We are excited to now offer Taltz as a treatment option for people in need of relief from the symptoms of AS. This approval further underscores Lilly's commitment to helping people living with rheumatic diseases."
The treatment is administered either alone or in combination with a conventional disease-modifying antirheumatic drug, corticosteroids, non-steroidal anti-inflammatory drugs, or analgesics.
However, the treatment is not approved for patients with a previous serious hypersensitivity, such as anaphylaxis, to ixekizumab or to any of the excipients. The drug may also increase the risk of infection.
Active ankylosing spondylitis affects the pelvic joints and spine, with chronic inflammatory back pain, stiffness, and impaired function and mobility. The disorder impacts approximately 1.6 million people in the US.
"Having new treatment options for the ankylosing spondylitis community is truly encouraging," Cassie Shafer, chief executive officer of the Spondylitis Association of America, said in a statement. "The ongoing focus to help people impacted by the disease will hopefully lead us to an eventual cure."
Taltz was tested in a pair of randomized, double-blind, placebo-controlled phase 3 studies involving 657 adult patients with active AS, COAST-V in patients who are biologic disease-modifying antirheumatic drug (bDMARD)-naïve, and COAST-W in patients who previously had an inadequate response or were intolerant to tumor necrosis factor inhibitors.
The safety observed for ankylosing spondylitis in the trials was consistent to the safety profile of patients with psoriasis treated with Taltz.
"Results from the Phase 3 clinical trial program in ankylosing spondylitis show that Taltz helped reduce pain and inflammation and improve function in patients who had never been treated with a bDMARD as well as those who previously failed TNF inhibitors," Philip Mease, MD, Swedish Medical Center/Providence St. Joseph Health and University of Washington, said in a statement. "This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS."