FDA approves Lilly Taltz (ixekizumab) treatment for active orthodlamitis
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Last Update: 2021-02-24
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Source: Internet
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Author: User
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today, Eli Lilly announced that the FDA has approved an expanded adaptation application for its new drug, Taltz (ixekizumab), for the treatment of active scoliosis (AS).Monoclonal antibody ixekizumab, selectively binds to lecytolein 17A (IL-17A) and inhibits its interaction with IL-17 receptors. IL-17A is a naturally occurring cytokine that participates in normal inflammatory and immune responses.ixekizumab inhibits the release of inflammatory cytokines and degenerative factors by inhibiting the signaling path path of IL-17 subjects, thereby alleviating the symptoms of inflammatory diseases.The approval of this expanded adaptation is based on the positive results of 2 Phase 3 trials OFT-V and COAST-W.COAST-V and COAST-W are designed to assess the effectiveness and safety of ixekizumab in AS patients who have not received anti-rheummatoid biologic drugs (bDMARD), as well as in patients with AS who do not respond or are insatiable with standard therapy tumor necrotizing agent inhibitors (TNFi).The main and secondary endpoints of the COAST trial were the proportion of patients who reached 40 (ASAS40) at 16 weeks, and asAS20.The COAST test was the first registered test to use ASASAS40 as the primary endpoint and reach the end point.In the ixekizumab group of COAST-V and COAST-W trials, 48% and 25% of patients reached the main endpoint ASASAS40, respectively, while the placebo group achieved 18% and 13%, respectively.in the ixekizumab group of COAST-V and COAST-W trials, 64 percent and 48 percent reached secondary endpoint ASASAS20, respectively, while the placebo group achieved 40 percent and 30 percent, respectively. (Drug Information Network)
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