Lilly's Taltz wins third approval, this time in patients with active ankylosing spondylitis
Lilly’s monoclonal antibody, Taltz, which is already approved for psoriatic arthritis and plaque psoriasis has won its third approval. The FDA has cleared its use in active ankylosing spondylitis (AS), a chronic inflammatory rheumatic disorder that affects the pelvic joints and spine, and can be characterized by inflammatory back pain, stiffness and impaired function and mobility.
Taltz — akin to Novartis’ $NVS blockbuster Cosentyx — inhibits IL-17A, a cytokine involved in inflammatory and immune responses. The drug, which will now also address the roughly 1.6 million Americans with AS, generated about $354 million in the second quarter.
Taltz was tested in two placebo-controlled Phase III studies that encompassed 657 AS patients to evaluate the proportion of patients the drug had an impact on, in terms of symptoms of pain, inflammation and function at 16 weeks. In the COAST-V trial, which included patients who had never been treated with an antirheumatic biologic, 48% of Taltz-treated patients achieved the response every four weeks versus 18% of placebo-treated patients (p<0.0001). In COAST-W trial, which involved patients who did not adequately benefit or were intolerant to tumor necrosis factor (TNF) inhibitors, 25% of patients treated with Taltz every four weeks achieved a response, versus 13% of patients given the placebo (p<0.05).
Four months ago, Lilly’s $LLY Taltz also cleared a late-stage study called COAST-X, in patients with a form of inflammatory arthritis in which there is no visible evidence of damage on X-rays — non-radiographic axial spondyloarthritis (nr-AxSpA).
Cosentyx is also approved for AS, as is UCB’s TNF blocker Cimzia.
