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FDA Approves Taltz for Non-Radiographic Axial Spondyloarthritis

Jun 01, 2020 3:47 pm

Today Eli Lilly announced that Taltz (ixekizumab) has received FDA approval for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA). Ixekizumab (an IL-17A inhibitor) would join certolizumab (TNF inhibitor) as the only 2 drugs approved by the FDA for nr-axSpA. 

Ixekizumab is currently FDA approved for the treatment of psoriasis, psoriatic arthritis, ankylosing spondilitis and, now, non-radiographic axial spondyloarthritis.

The approved dose for nr-axSpA is 80 mg every 4 weeks given subcutaneously

FDA approval is based on the results from the 52 week, Phase 3 COAST-X trial, showing ASAS 40 responses (30%) Taltz 80 mg every four weeks to be superior to placebo (13%). 

 It is unclear how many people have nr-axSpA in the USA, but it estimated that among the 2.3 million with axial spondyloarthritis, nearly half could have nr-axSpA. 


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