每两周注射一次的长效多发性硬化症新药Plegridy(peginterferon beta-1a)获准上市！
近日，美国FDA已批准百健艾迪制药公司(Biogen Idec)长效多发性硬化症药物Plegridy。Plegridy已于7 月获得欧盟委员会批准，这款药物旨在减少多发性硬化症的复发及延缓病程。
Plegridy是一种聚乙二醇化干扰素β-1a药物，开发用于复发型多发性硬化症的治疗，已被证明能够显著减轻疾病的活动，包括复发次数、核磁共振脑部病变及残疾进展。Plegridy利用聚乙二醇化技术来延长干扰素β-1a的半衰期，延长其在体内的循环时间，能够减少用药次数，只需每两周经皮下注射一次。可通过注射笔Plegridy Pen进行给药，Plegridy Pen是一种新的预充式即用型自动注射笔。Plegrid的获批，是基于全球性关键III期ADVANCE研究的数据。在过去16个月内，Plegridy是FDA 批准的第四款百健艾迪药物。
批准日期：2014年8月15日；公司：Biogen Idec
PLEGRIDY (聚乙二醇干扰素β-1a)注射用，为皮下注射
美国初次批准：2014
适应证和用途
PLEGRIDY是一种干扰素β适用为多发性硬化症复发型病人的治疗。
剂量和给药方法
⑴ 只为皮下注射•
⑵ 推荐剂量：每14天125 µg•
⑶ PLEGRIDY剂量应被点滴调整，开始在第1天用63µg，在第15天94µg，和在第29天125µg (完全剂量)
⑷ 一位卫生保健专业人员硬训练病人用预充填笔或注射器自身皮下注射给药适当技术
⑸ 在治疗天用镇痛药和/或退热药可能有助减轻流感样症状
剂型和规格
⑴ 注射：125 µg每0.5 mL溶液在一个一次性剂量预充填笔
⑵ 注射启动包：63 µg每0.5 mL溶液在一个一次性剂量预充填笔和94 µg每0.5 mL溶液在一个一次性剂量预充填笔
⑶ 注射：125 µg每0.5mL溶液在一个一次性剂量预充填注射器
⑷ 注射启动包：63 µg每0.5 mL溶液在一个一次性剂量预充填注射器和94 µg每0.5mL 溶液在一个一次性剂量预充填注射器
禁忌证
对天然或重组干扰素β或聚乙二醇干扰素，或制剂的任何其他组分超敏性病史
警告和注意事项
⑴ 肝损伤：监视肝功能测试；监视病人肝损伤体征和症状；如发生肝损伤考虑终止PLEGRIDY
⑵ 抑郁和自杀：劝告病人立即报告抑郁或自杀意念任何症状至其卫生保健提供者；如发生抑郁考虑终止PLEGRIDY。
⑶ 癫痫发作：癫痫发作伴随干扰素β的使用。当给予PLEGRIDY至有癫痫发作疾病病人谨慎对待
⑷ 过敏反应和其他过敏性反应：用干扰素β治疗曾报道严重性过敏性反应作为罕见并发症。如发生严重性过敏性反应终止PLEGRIDY。
⑸ 注射部位反应：改变注射部位或如存在坏死考虑终止PLEGRIDY
⑹ 充血性心力衰竭：有预先存在显著心脏病对心脏症状的恶化监视病人
⑺ 外周血细胞计数减低：监视完全血细胞计数
⑻ 自身免疫疾病：如发生一种新自身免疫疾病考虑终止PLEGRIDY
不良反应
最常见不良反应(发生率≥10%和用PLEGRIDY比用安慰剂更频至少2%)是注射部位红斑，流感样疾病，发热，头痛，肌肉痛，寒战，注射部位疼痛，无力，注射部位瘙痒，和关节痛
特殊人群中使用
⑴ 妊娠：根据动物数据，可能致胎儿危害
⑵严重肾受损：监视不良反应

Plegridy (Peginterferon Beta-1a Injection for Subcutaneous Use)

Indication
PLEGRIDY™ (peginterferon beta-1a) is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS).
Important Safety Information
Before beginning treatment, you should discuss with your healthcare provider the potential benefits and risks associated with PLEGRIDY.
PLEGRIDY can cause serious side effects. Call your healthcare provider right away if you have any of the symptoms listed below.
•Liver problems, or worsening of liver problems including liver failure and death. Symptoms may include yellowing of your skin or the white part of your eye, nausea, loss of appetite, tiredness, bleeding more easily than normal, confusion, sleepiness, dark colored urine, and pale stools. During your treatment with PLEGRIDY you will need to see your healthcare provider regularly. You will have regular blood tests to check for these possible side effects
•Depression or suicidal thoughts. Symptoms may include new or worsening depression (feeling hopeless or bad about yourself), thoughts of hurting yourself or suicide, irritability (getting upset easily), nervousness, or new or worsening anxiety
Do not take PLEGRIDY if you are allergic to interferon beta or peginterferon beta-1a, or any of the other ingredients in PLEGRIDY.
Before taking PLEGRIDY, tell your healthcare provider if you:
•Are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior
•Have or had liver problems, low blood cell counts, bleeding problems, heart problems, seizures (epilepsy), thyroid problems, or any kind of autoimmune disease
•Take prescription and over-the-counter medicines, vitamins, and herbal supplements
•Are pregnant or plan to become pregnant. It is not known if PLEGRIDY will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with PLEGRIDY
•Are breastfeeding or plan to breastfeed. It is not known if PLEGRIDY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use PLEGRIDY
PLEGRIDY can cause additional serious side effects including:
•Serious allergic reactions. Serious allergic reactions can happen quickly. Symptoms may include itching, swelling of the face, eyes, lips, tongue, or throat, trouble breathing, feeling faint, anxiousness, skin rash, hives, or skin bumps
•Injection site reactions. PLEGRIDY may commonly cause redness, pain or swelling at the place where the injection was given. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected and it does not heal within a few days. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider
•Heart problems, including congestive heart failure. While PLEGRIDY is not known to have any direct effects on the heart, some people who did not have a history of heart problems developed heart muscle problems or congestive heart failure after taking interferon beta. If you already have heart failure, PLEGRIDY may cause your heart failure to get worse. Call your healthcare provider right away if you have worsening symptoms of heart failure such as shortness of breath or swelling of your lower legs or feet while using PLEGRIDY
◦Some people using PLEGRIDY may have other heart problems, including low blood pressure, fast or abnormal heart beat, chest pain, heart attack, or a heart muscle problem (cardiomyopathy)
•Autoimmune diseases. Problems with easy bleeding or bruising (idiopathic thrombocytopenia), thyroid gland problems (hyperthyroidism and hypothyroidism), and autoimmune hepatitis have happened in some people who use interferon beta
•Blood problems and changes in your blood tests. PLEGRIDY can decrease your white blood cells or platelets, which can cause an increased risk of infection, bleeding or anemia, and can cause changes in your liver function tests. Your healthcare provider should do blood tests while you use PLEGRIDY to check for side effects
•Seizures. Some people have had seizures while taking PLEGRIDY, including people who have never had seizures before
The most common side effects of PLEGRIDY include:
•Flu-like symptoms. Many people who take PLEGRIDY have flu-like symptoms early in the course of therapy. These symptoms are not really the flu. You cannot pass it on to anyone else. Symptoms may include headache, muscle and joint aches, fever, chills or tiredness
◦You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers and drinking plenty of water. For many people, these symptoms lessen or go away over time
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
美国食品和药物管理局（FDA）已批准PLEGRIDYTM（聚乙二醇干扰素的β-1A），对人多的复发形式的新疗法硬化症（RMS）。 PLEGRIDY，在RMS中批准使用的唯一的聚乙二醇化的β干扰素，将给药一次，每两周，并且可以与PLEGRIDY笔，一个新的，准备使用的自动注射器或预充式注射器经皮下给药。
“PLEGRIDY提供MS患者强劲效能，既定的干扰素类，比其他β干扰素治疗显著减少注射一致的安全性，说：”乔治·Scangos，博士，Biogen Idec公司的首席执行官。 “PLEGRIDY代表了干扰素类最显著创新了十多年，而且是我们的坚定承诺，以改善MS患者和那些谁关心他们的生活的结果。”
PLEGRIDY的FDA的批准是基于进行β干扰素，前进，涉及1500多MS患者的最大的关键性研究的一个结果。进步是一个为期两年，第三期，安慰剂对照（中一年级）的研究，评估PLEGRIDY的皮下给药的疗效和安全性。分析所有主要和次要疗效终点发生在今年1月底。第一年之后，服用安慰剂的患者接受PLEGRIDY为研究期间。
在前进临床试验的第一年，PLEGRIDY与安慰剂相比（P = 0.0007）给药一次，每两周显著降低年化复发率（ARR）为一年36％。 PLEGRIDY减少了12周的风险证实残疾进展，如通过扩展残疾状态量表测定，38％（P = 0.0383），与安慰剂相比。 PLEGRIDY也显著减少新钆增强[钆+]皮损数目86％（p0.0001），并减少新的或新扩大的T2高信号病灶67％（p0.0001）与安慰剂相比。
最常见的不良反应为注射部位反应，流感样病例，发热，头痛，肌肉痛，寒战，注射部位疼痛，无力，注射部位瘙痒和关节疼痛。提前两年的安全数据与在第一年观察到的安全性结果是一致的。
“PLEGRIDY是生活与MS，提供了一个经过验证的安全性，药效强劲，并创新提供系统管理的每二周给药方案的人一个引人注目的新的治疗选择，”彼得·韦德，医学博士，在曼德尔的神经科医疗主任在康涅狄格州哈特福德中心综合多发性硬化症护理和神经科学的研究。 “作为一名神经科医生治疗，相信这些属性将吸引MS患者谁看的用药次数少了行之有效。”
PLEGRIDY已经由欧盟委员会最近批准。
“它总是鼓励有更多的治疗方案，可以帮助MS患者管理自己的疾病在我们走向我们最终的永远终结MS的目标，”蒂莫西库切博士，首席宣传，服务和研究人员在美国国家多发性硬化症协会说。
有关PLEGRIDY更多信息，处方信息和财政援助方案参观PLEGRIDY.com或biogenidec.com。
关于PLEGRIDY™
PLEGRIDY是用于MS的复发形式，其中，干扰素β-1a被PEG化以延长其半衰期，以允许较不频繁的给药时程所表示的新的皮下注射治疗。 PLEGRIDY是干扰素类的MS治疗中的一员。
从PLEGRIDY的ADVANCE研究的临床和MRI数据显示在复发，残疾进展和MS病变的数目减少时，与安慰剂组相比，以及进一步支持其临床疗效信息。 PLEGRIDY的安全性和耐受提前观察到了与既定的MS干扰素疗法是一致的。
PLEGRIDY的推荐剂量为125毫克皮下注射每14天。患者应开始治疗，63微克的第一天。第15天，剂量增加至94微克，达到29天的全剂量为125微克。
严重的肝损伤，包括肝炎，自身免疫性肝炎，以及严重肝衰竭罕见的病例报告与干扰素β。肝酶和肝损伤升高已观察到，在临床研究中使用PLEGRIDY的。抑郁，自杀意念和自杀的报道在接受β干扰素的患者。癫痫发作也与使用干扰素β有关。过敏性反应等严重过敏性反应与干扰素β治疗的罕见并发症。注射部位反应，包括注射部位坏死，可发生与使用皮下干扰素β。
充血性心脏衰竭，心肌病和心肌病充血性心脏衰竭发生在接受β干扰素的患者。 β干扰素可以在所有的细胞系下降引起外周血计数，包括全血细胞减少和严重的血小板减少症的罕见情况。多个靶器官的自身免疫性疾病，包括特发性血小板减少症，超和甲状腺功能减退症和自身免疫性肝炎的报道与干扰素β。