新一代IL-17A单抗药物Taltz(Ixekizumab)注射剂被FDA批准上市 近日，美国FDA批准Eli Lilly的Taltz(ixekizumab) 来治疗中度至重度斑块状银屑病。银屑病是一种皮肤发红和剥落的皮肤状况。银屑病是一种自身免疫性的紊乱，通常发生在家族史患者，最常在15至35岁开始。银屑病最常见的形式是斑块状银屑病，病人形成厚厚的红色皮肤片状，银白色鳞片状结构。 FDA的药物评价和研究中心办公室主任医学博士Julie Beitz，说:'今天的批准为斑块状银屑病患者提供了一种重要的治疗选择，帮助缓解皮肤刺激和皮肤不适'。 银屑病是一种皮肤发红和剥落的皮肤状况。银屑病是一种自身免疫性的紊乱，通常发生在家族史患者，最常在15至35岁开始。银屑病最常见的形式是斑块状银屑病，病人形成厚厚的红色皮肤片状，银白色鳞片状结构。 Taltz 的活性成分是一种将绑定到一种蛋白质(白细胞介素 (IL)-17A)的抗体 (ixekizumab)。通过与蛋白质结合，ixekizumab 是能够抑制炎症反应，在斑块性银屑病的发展中发挥重要的作用。 Taltz为注射治疗，针对那些全身治疗（治疗使用的物质通过口服或注射后，能进入血液）、 光疗 （紫外线光治疗）或两者的组合的患者。 批准日期：2016年3月25日 公司：礼来公司 TALTZ（ixekizumab）注射，皮下使用 最初美国批准：2016年 作用机理 Ixekizumab是人源化的IgG4单克隆抗体做选择性地与白介素17A（IL-17A）的细胞因子结合并抑制其与所述IL-17受体相互作用。 IL-17A是一个天然存在的细胞因子并在正常的炎症和免疫应答涉及。 Ixekizumab抑制炎性细胞因子和趋化因子的释放。 适应症和用法 TALTZ™是一种人性化的白细胞介素17A拮抗剂适用于治疗成年人的中度至重度牛皮癣谁是全身治疗或光疗的候选人。 用法用量 通过皮下注射给药。 推荐剂量是在第0周160毫克（二80毫克注射），其次是80毫克在周2，4，6，8，10，和12中，然后80毫克每星期4 剂型和规格 自动注射器 注射：在单剂量预填充自动注射器80毫克/毫升溶液。 预充式注射器 注射：在单剂量预装填注射器80毫克/毫升溶液。 禁忌症 严重超敏反应到ixekizumab或任何赋形剂。 警告和注意事项 感染：严重感染时有发生。指导患者如果症状或临床上重要的慢性或急性感染症状出现，应及早求医。如果严重感染的发展，停止TALTZ直至感染消失。 结核病（TB）：开始治疗前评估结核病。 过敏症：如果发生严重的过敏反应，立即停止并启动TALTZ适当的治疗。 炎症性肠病：克罗恩病和溃疡性结肠炎，包括加重，在临床试验期间发生的。谁是处理与TALTZ并有炎症性肠病患者shoulderstand进行密切监测。 不良反应 与治疗TALTZ关联最常见（≥1％）的不良反应是注射部位反应，上呼吸道感染，恶心和癣感染。 报告可疑的不良反应，请联系礼来公司在1-800-545-5979（1-800-LillyRx）或FDA电话1-800-FDA-1088或www.fda.gov/medwatch。 药物相互作用 活疫苗：活疫苗不宜与TALTZ给出。 包装规格/储存与处理 附送TALTZ注射如何是无菌的，不含防腐剂，透明和无色到稍微黄色的，可以在单剂量预填充自动注射器或预充式单剂量注射器递送80毫克ixekizumab溶液。 TALTZ是作为： 包装规格NDC码 自动注射器 1箱80毫克单剂量0002-1445-11 2 0002-1445-27 80毫克单剂量纸箱 3 0002-1445-09 80毫克单剂量纸箱 预充式注射器 1箱80毫克单剂量0002-7724-11 2 0002-7724-27 80毫克单剂量纸箱 3 0002-7724-09 80毫克单剂量纸箱 存储和处理TALTZ无菌，无防腐剂。丢弃任何未使用的部分。 TALTZ必须避光直到使用 储存在2℃冷藏至8°C（36°F至46°F）。 不要冻结。不要使用TALTZ如果它已被冻结。 不要摇晃。 丢弃在抗穿刺容器使用后TALTZ单剂量自动注射器或注射器。 不与天然橡胶胶乳制成。 Taltz® (ixekizumab) Receives U.S. FDA Approval for the Treatment of Moderate-to-Severe Plaque Psoriasis U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Taltz should not be used in patients with a previous hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz is designed to specifically target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis. Psoriasis is a chronic, immune disease that affects the skin.2 Psoriasis affects approximately 7.5 million Americans, approximately 20 percent of whom have moderate-to-severe plaque psoriasis.3 Plaque psoriasis is the most common form of the condition and appears as raised, red patches of skin covered with a silvery, white buildup of dead skin cells, which are often painful or itchy.3,4 The exact cause of psoriasis is unknown, though genetics and environmental factors are known to play a role in the development of the disease.3 "Many people living with psoriasis are still looking for a treatment that will successfully manage the magnitude of this disease," said Alex Azar, president, Lilly USA, LLC. "With the approval of Taltz, we are proud to provide patients with a new treatment that may help patients experience virtually or completely clear skin." The FDA approval of Taltz was based on findings from the largest Phase 3 trial program approved to date—more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries.5 This number includes patients who began the trial on Taltz or placebo, or active comparator (U.S.-approved etanercept).6 This clinical program included three double-blind, multicenter, Phase 3 studies—UNCOVER-1, UNCOVER-2 and UNCOVER-3—which demonstrated the safety and efficacy of Taltz in patients with moderate-to-severe plaque psoriasis. All three studies evaluated the safety and efficacy of Taltz (80 mg every two weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received U.S.-approved etanercept (50 mg twice a week) for 12 weeks. UNCOVER-1 and UNCOVER-2 also evaluated response rates with Taltz during the maintenance period through 60 weeks. In these studies, the co-primary efficacy endpoints at 12 weeks were a 75 percent improvement in the composite Psoriasis Area Severity Index (PASI) score and static Physician's Global Assessment (sPGA) 0 or 1 and at least a 2-point improvement from baseline. PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions (each graded on a zero to four scale), weighted by the body surface area of involved skin, while the sPGA is the physician's assessment of severity of a patient's psoriasis lesions overall at a specific point in time and is a required measure the FDA uses to evaluate effectiveness. In all three studies, at 12 weeks, 87 to 90 percent of patients treated with Taltz saw a significant improvement of their psoriasis plaques (PASI 75).  In addition, 81 to 83 percent of patients treated with Taltz achieved sPGA 0 or 1. The majority of patients treated with Taltz, 68 to 71 percent, achieved virtually clear skin (PASI 90) and 35 to 42 percent of patients saw complete resolution of their psoriasis plaques (PASI 100, sPGA 0). Among those patients treated with placebo, 7 percent or fewer achieved PASI 75, 7 percent or fewer achieved sPGA 0 or 1, 3 percent or fewer achieved PASI 90 and 1 percent or fewer achieved PASI 100 and sPGA 0. In UNCOVER-1 and UNCOVER-2, of patients who responded to Taltz (sPGA 0 or 1 and at least a 2-point improvement from baseline) at 12 weeks, 75 percent consistently maintained that response at the 60-week endpoint. Taltz was also statistically superior to U.S.-approved etanercept at all skin clearance levels, including PASI 75 and sPGA 0 or 1 at 12 weeks. In an integrated analysis of the U.S. sites in the two active comparator studies—UNCOVER-2 and UNCOVER-3—the respective response rates for Taltz vs. U.S.-approved etanercept were 87 percent vs. 41 percent for PASI 75 and 73 percent vs. 27 percent for sPGA 0 or 1.  Information regarding the safety of Taltz is drawn from a database of 4,204 patients with moderate-to-severe plaque psoriasis who volunteered in both controlled and uncontrolled clinical trials. Taltz may increase the risk of infection. Patients treated with Taltz had a higher rate of infections than patients treated with placebo (27 percent vs. 23 percent). Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in patients treated with Taltz compared to placebo. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves. Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations. See Important Safety Information below. In UNCOVER-2 and UNCOVER-3, the rate of serious adverse events during the controlled induction period (weeks 0-12) was 0.7 percent for U.S.-approved etanercept and 2 percent for Taltz, and the rate of discontinuation from adverse events was 0.7 percent for U.S.-approved etanercept and 2 percent for Taltz. The incidence of infections was 18 percent for U.S.-approved etanercept and 26 percent for Taltz. The rate of serious infections was 0.3 percent for both U.S.-approved etanercept and Taltz. "Complete clearance of skin plaques is an important treatment goal for psoriasis," said Craig Leonardi, M.D., lead study author and clinical professor of dermatology at St. Louis University School of Medicine. "With Taltz, physicians now have a choice that can help patients achieve virtually clear or completely clear skin; in fact, four out of 10 achieved completely clear skin. With these study results, physicians can reassure patients that consistent results can be maintained with Taltz." Indications and Usage Taltz® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. WARNINGS AND PRECAUTIONS Infections Taltz may increase the risk of infection. The Taltz group had a higher rate of infections than the placebo group (27% vs. 23%). Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves. Pre-Treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment. Hypersensitivity Serious hypersensitivity reactions, including angioedema and urticaria (each <</span> 0.1%), occurred in the Taltz group in clinical trials. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy. Inflammatory Bowel Disease Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn's disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease. Immunizations Prior to initiating therapy with Taltz, consider completion of all age appropriate immunizations according to current immunization guidelines. Live vaccines should not be given with Taltz. ADVERSE REACTIONS Most common adverse reactions (>1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. See accompanying Prescribing Information and Medication Guide. See Instructions for Use included with the device. IX HCP ISI 22MAR2016 About Taltz® Taltz® (ixekizumab) is a humanized IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.  Taltz inhibits the release of pro-inflammatory cytokines and chemokines. About the UNCOVER Studies The UNCOVER-1, UNCOVER-2 and UNCOVER-3 studies are double-blind, multicenter, Phase 3 studies evaluating more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries. All three studies evaluated the safety and efficacy of different dosing regimens of Taltz (80 mg every two or four weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received U.S.-approved etanercept (50 mg twice a week) for 12 weeks. In UNCOVER-1 and UNCOVER-2, safety and efficacy of Taltz was further evaluated through 60 weeks. About Moderate-to-Severe Plaque Psoriasis Psoriasis is a chronic, immune disease that affects the skin.3 It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells.3 It is the most common inflammatory disease in the United States, affecting as many as 7.5 million Americans and an estimated 125 million people worldwide.3 The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells.3 Approximately 20 percent of people with psoriasis have moderate-to-severe plaque psoriasis. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ac96658a-d7dc-4c7c-8928-2adcdf4318b2