新型IL17A受体抗体Siliq(brodalumab)获FDA批准，用于治疗顽固性银屑病。
近日，美国食品和药物管理局批准了Siliq（brodalumab）用于治疗成人中度至重度斑块型银屑病。Siliq是一种注射剂型。主要用于那些全身治疗或光疗以及其他治疗没有效果的银屑病患者。
“中度至重度斑块型银屑病患者可以引起明显的皮肤刺激和不适，而今天批准的药物为银屑病患者的治疗多了一份选择，” FDA的药物评价和研究中心的药物评估办公室主任Julie Beitz博士称，“患者和医护工作者在考虑使用Siliq进行治疗之前用综合考虑其药效和风险。”
银屑病是一种皮肤疾病，患者皮肤发红、剥落。银屑病是一种自身免疫性疾病，通常发生在有家族病史的患者中，最常见于15岁到35岁人群。银屑病最常见的形式是斑块型银屑病，病人患处发展为皮肤增厚、潮红，并呈银白色鳞屑状。
Siliq的活性成分（Brodalumab）与产生炎症反应的蛋白质结合，从而达到抑制斑块状银屑病的目的。
批准日期：2017年2月15日；公司：Valeant Pharmaceuticals International，Inc.
SILIQ(布罗达单抗[brodalumab])注射液、单剂量预充式注射器 ，为皮下使用
在美国初次批准：2017
作用机制
Brodalumab是一种人单克隆IgG2抗体选择性地结合至人IL-17RA和抑制它与细胞因子IL-17A，IL-17F，IL-17C，IL-17A/F异源二聚体和IL-25相互作用。IL-17RA是一种蛋白表达在细胞表面和是被多种IL-17家族细胞因子复合物利用需要的组分。阻断IL17RA抑制IL-17细胞因子-诱导反应包括促炎性细胞因子和趋化因子的释放。
适应证和用途
SILIQ是一种人白细胞介素-17受体A(IL-17RA)拮抗剂适用为中度至严重斑块银屑病是对全身治疗或光治疗备选者和对其他全身治疗已失败或已丧失反应成年患者的治疗。
剂量和给药方法
●通过皮下注射给予SILIQ 210mg在周0，1，和2接着每2周210mg。
剂型和规格
● 注射液：210mg/1.5mL溶液在一个单剂量充填的注射器。
禁忌证
● 克罗恩病
警告和注意事项
●感染：曽发生严重的感染。在有慢性感染或复发感染病史患者中开始SILIQ前考虑风险和获益。指导患者如发生临床上重要的慢性或急性感染的体征或症状寻求医学建议。如发生一种严重的感染，终止SILIQ直至感染解决。
●结核(TB)：开始用SILIQ治疗前评价患者对TB感染。
●克罗恩病：临床试验期间发生克罗恩病。如克罗恩病患者用SILIQ时发生终止SILIQ。
●免疫接种：用SILIQ避免同时地利用活疫苗。
不良反应
最常见不良反应(发生率 ≥1%)为关节痛，头痛，疲乏，腹泻，口咽痛，恶心，肌痛，注射部位反应，流感，中性粒细胞减少,和癣感染。
包装供应/贮存和处置
供应
SILIQ(brodalumab)注射液是可得到在一个单剂量充填的注射器含一个无菌，无防腐剂透明至微乳白色，无色 至略微黄色溶液可能含少许 半透明至白色，无定形的颗粒。
● NDC 0187-0004-02：两支210mg/1.5mL单剂量充填的注射器的纸盒。
贮存和处置
● 贮存在冰箱在2°C至8°C(36°F至46°F)在原始纸盒中贮存期间避光和物理损伤保护。
● 当需要时，充填的注射器可被贮存在室温至最高77°F(25°C)在原始纸盒有避光和热源保护共最长单次14天阶段。一旦充填的注射器已到达室温，不要放回至冰箱。在室温14天后遗弃。
● 不要冻结。
● 不要摇晃。
完整处方资料附件：
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1a550c33-456a-4833-814e-8591aea7c688&type=display
SILIQ (BRODALUMAB) APPROVED BY THE US FDA
FOR ADULT PATIENTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS
US Partner Valeant Pharmaceuticals
AstraZeneca's partner Valeant Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has approved Siliq (brodalumab) injection for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
Siliq is an IL-17 receptor monoclonal antibody for patients with moderate-to-severe plaque psoriasis, a chronic, debilitating skin disease that causes red patches of skin covered with silvery scales.
About Siliq
Siliq (brodalumab) is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signalling by blocking the binding of several types of IL-17 to the receptor. By stopping IL-17 from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes.
The FDA approval is based on data from the three AMAGINE Phase III pivotal studies that demonstrated that Siliq has an effective mechanism of action that delivers clinical benefit and could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. At the 210mg dose, Siliq was shown to be efficacious in total skin clearance of psoriasis with approximately twice as many patients on Siliq achieving total skin clearance compared to ustekinumab at week 12 in two replicate comparator trials involving over 2,400 patients.
Siliq, brodalumab (Lumicef) (KHK4827) (formerly AMG 827)
Dosage Forms & Strengths
solution for SC injection
•210mg/1.5mL (single-dose prefilled syringe)
Psoriasis
Indicated for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies
210 mg SC at Weeks 0, 1, and 2, THEN
210 mg SC q2wk
If an adequate response has not been achieved after 12-16 weeks, consider discontinuing therapy; continued treatment beyond 16 weeks in patients who have not achieved an adequate response is not likely to result in greater success
Dosing Considerations
eva luate patients for tuberculosis (TB) prior to initiating (see Cautions)
Safety and efficacy not established
HOW SUPPLIED/STORAGE AND HANDLINGHow Supplied
SILIQ (brodalumab) Injection is available in a single-dose prefilled syringe containing a sterile, preservative-free clear to slightly opalescent, colorless to slightly yellow solution that may contain a few translucent to white, amorphous particles.
• NDC 0187-0004-02: Carton of two 210 mg/1.5 mL single-dose prefilled syringes
Storage and Handling
• Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light and physical damage during storage.
• When necessary, prefilled syringes can be stored at room temperature up to a maximum of 77°F (25°C) in the original carton for a maximum single period of 14 days with protection from light and sources of heat. Once the prefilled syringe has reached room temperature, do not place back into the refrigerator. Discard after 14 days at room temperature.
• Do not freeze.
• Do not shake.
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) before the patient starts using SILIQ, and each time the prescription is renewed, as there may be new information they need to know.
Suicidal Thoughts and Behavior
Instruct patients and their caregivers to monitor for the emergence of suicidal thoughts and behavior and promptly seek medical attention if the patient experiences suicidal thoughts, new or worsening depression, anxiety, or other mood changes [see Warnings and Precautions].
Instruct patients to carry the wallet card provided and to call the National Suicide Prevention Lifeline at 1-800-273-8255 if they experience suicidal thoughts.
SILIQ REMS Program
Because of the observed suicidal thoughts and behavior in subjects treated with SILIQ, SILIQ is available only through a restricted program called the SILIQ REMS Program [see Warnings and Precautions]. Inform the patient of the following:
• Patients must enroll in the program [see Warnings and Precautions].
• Patients will be given a SILIQ Patient Wallet Card that they should carry with them at all times. This card describes symptoms which, if experienced, should prompt the patient to immediately seek medical eva luation. Advise the patient to show the SILIQ Patient Wallet Card to other treating healthcare providers.
SILIQ is available only from certified pharmacies participating in the program. Therefore, provide patients with the telephone number and website for information on how to obtain the product.
Infections
Inform patients that SILIQ may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to their healthcare providers and to contact their healthcare providers if they develop any signs or symptoms of infection [see Warnings and Precautions].
Crohn’s Disease
Instruct patients to seek medical advice if they develop signs and symptoms of Crohn’s disease [see Warnings and Precautions].
Instructions for Injection
Instruct the patient to perform the first self-injection under the guidance and supervision of a qualified healthcare professional for proper training in subcutaneous injection technique.
Instruct patients who are self-administering to inject the full dose of SILIQ [see Dosage and Administration and Instructions for Use].
Instruct patients or caregivers in the technique of proper syringe and needle disposal [see Instructions for Use].