Eli Lilly has announced that the US FDA has approved Taltz (ixekizumab) for the treatment of active ankylosing spondylitis. The strength indicated for the treatment is 80 mg/mL.
The drug was earlier approved for the treatment of moderate to severe plaque psoriasis in adult patients and adults with active psoriatic arthritis.
The drug can be indicated as monotherapy or in combination with the disease-modifying antirheumatic drug (e.g. sulfasalazine), corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs) and/or analgesics.
The approval is based on the two studies: COAST-V (biologic disease-modifying antirheumatic drug (bDMARD)-naïve patients) and COAST-W (patients with inadequate response or were intolerant to tumor necrosis factor (TNF) inhibitors). The primary endpoint in both studies was the Assessment of Spondyloarthritis International Society 40 (ASAS40) response compared to placebo at week 16. Taltz showed significant and clinically meaningful improvements in signs and symptoms. In COAST-V, 48% patients showed response vs. 18% in patients treated with placebo. In COAST-W, 25% patients showed response vs. 13% in patients on placebo.
The safety profile was consistent with the safety profile of other indications.