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FDA expands Taltz approval for ankylosing spondylitis
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The FDA has extended approval for ixekizumab injection 80 mg/mL to treat adults with ankylosing spondylitis – or radiographic axial spondyloarthritis - according to an Eli Lilly press release.
Ixekizumab (Taltz) was originally approved by the FDA in 2016 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy, and subsequently approved in 2017 for the treatment of 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 of U.S. Immunology at Eli Lilly, said in a press release. “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 FDA based its expanded approval on the results of two randomized, double-blind, placebo-controlled phase 3 trials of adult patients with ankylosing spondylitis (n=657): COAST-V, consisting of patients who were biologic DMARD-naïve, and COAST-W, comprised of patients who had previously exhibited an inadequate response or were intolerant to TNF inhibitors. The primary endpoint of both studies was the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response compared to placebo at 16 weeks.
According to study results, patients treated with ixekizumab in both studies achieved statistically significant and clinically meaningful improvements in signs and symptoms, as defined by ASAS40 response, compared to placebo. At 16 weeks, 48% of ixekizumab-treated patients in the COAST-V trial achieved ASAS40 responses compared with 18% of patients on placebo (P<.0001), while 25% of ixekizumab-treated patients in the COAST-W achieved ASAS40 response vs. 13% of those on placebo.
“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 biologic DMARD 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 the release. “This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS.”
According to the FDA, the most common adverse events observed were injection site reactions, upper respiratory tract infections, nausea and tinea infections. Overall, the safety profiles observed in patients with ankylosing spondylitis were consistent with the safety profile in patients with psoriasis.
“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 the release. “The ongoing focus to help people impacted by the disease will hopefully lead us to an eventual cure.”