Eli Lilly's Taltz expanded in US for use in active ankylosing spondylitis

Eli Lilly announced Monday that the FDA has expanded the label for Taltz (ixekizumab) to include the treatment of adults with active ankylosing spondylitis, also referred to as radiographic axial spondyloarthritis. Rebecca Morison, vice president for the company's US immunology division, said "ankylosing spondylitis is a challenging disease that can cause severe back pain and if left untreated, can significantly impact patient mobility," adding that "we are excited to now offer Taltz as a treatment option for people in need of relief from the symptoms of [this condition]." 

Approval was supported by data from two Phase III studies involving 657 adults with active ankylosing spondylitis. The COAST-V trial enrolled patients who are biologic disease-modifying antirheumatic drug-naïve, while the COAST-W study involved patients who previously had an inadequate response or were intolerant to TNF inhibitors. Data unveiled last October showed that in both trials, the treatment was linked to a significant and clinically meaningful improvement in the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) over 16 weeks versus placebo. 

Taltz was initially approved in the US in 2016 for the treatment of adults with moderate-to-severe plaque psoriasis and later expanded to include adults with active psoriatic arthritis. The IL-17A-targeting antibody also received FDA approval last year for a label update to include data for psoriasis involving the genital area.

Sales of Taltz in the second quarter surged 61% year-on-year to $353.8 million, including 54% revenue growth in the US due to higher demand.   

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