欢迎注册 找回密码

QQ登录

只需一步,快速开始

扫一扫,访问微社区

运动神经元病互助家园

查看: 1776|回复: 2

关于美国FDA食品与药物监管局通过依达拉奉治疗ALS

[复制链接]

该用户从未签到

发表于 2017-5-7 20:56:18 | 显示全部楼层 |阅读模式
昨天,在ALS家园里看到有网友发帖。重磅消息:美国22年以来首次推出治疗运动神经元药物Radicava (edaravone) 依达拉奉。
然后,今天我在中国医院询问此药。国内非常普及以前用于其它神经疾病治疗,但是未包括运动神经元。最后本人通过百度搜索美国食品与药物监管局官方网站,查询一下发表来自FDA对依达拉奉公告文章。希望各位患者朋友能够有帮助! 美国FDA官方网站:www.fda.gov( 类似中国药物监管局GMP标准机构)。希望大家有兴趣自愿使用此药能够交流一下,特别有病友最近前往北京上海(北三医、协和、301、华山、瑞金、中山)大型医院可否问下ALS知名医师对于(edaravone) 依达拉奉药物治疗ALS如何使用?是否继续与力如太同时服用,还有(edaravone) 依达拉奉使用周期如何?多少时间注射一次,是否连续长期注射还是每次注射完闭,过段时间再继续注射。
恳求近期,前往北京会诊北京三医樊东升主任、北京协和医院崔丽英主任的朋友,能够帮忙询问关于这个药物的使用方法和力如太与此药相互作用。
希望大家,跟帖。能够回复有效信息。谢谢!!
The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.
“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.”
ALS is a rare disease that attacks and kills the nerve cells that control voluntary muscles. Voluntary muscles produce movements such as chewing, walking, breathing and talking. The nerves lose the ability to activate specific muscles, which causes the muscles to become weak and leads to paralysis. ALS is progressive, meaning it gets worse over time. The Centers for Disease Control and Prevention estimates that approximately 12,000-15,000 Americans have ALS. Most people with ALS die from respiratory failure, usually within three to five years from when the symptoms first appear.
Radicava is an intravenous infusion given by a health care professional. It is administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug-free.
The efficacy of edaravone for the treatment of ALS was demonstrated in a six-month clinical trial conducted in Japan. In the trial, 137 participants were randomized to receive edaravone or placebo. At Week 24, individuals receiving edaravone declined less on a clinical assessment of daily functioning compared to those receiving a placebo.
The most common adverse reactions reported by clinical trial participants receiving edaravone were bruising (contusion) and gait disturbance.
Radicava is also associated with serious risks that require immediate medical care, such as hives, swelling, or shortness of breath, and allergic reactions to sodium bisulfite, an ingredient in the drug. Sodium bisulfite may cause anaphylactic symptoms that can be life-threatening in people with sulfite sensitivity.
The FDA granted this drug orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
The FDA granted approval of Radicava to Mitsubishi Tanabe Pharma America, Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
###

真情互助,携手抗冻,我们是一家人!
塑料油论坛LED广告
帖子凝聚着我们的辛劳,回帖是对我们的鼓励,在您得到帮助的同时,请您尽可能的去帮助他人.真情互助,携手抗冻,因为我们是一家人!
  • TA的每日心情
    奋斗
    2019-8-2 12:12
  • 签到天数: 451 天

    [LV.9]以坛为家II

    发表于 2017-5-9 12:12:04 | 显示全部楼层
    前两年就听说过 作用有待考证
    真情互助,携手抗冻,我们是一家人!
    塑料油论坛LED广告
    帖子凝聚着我们的辛劳,回帖是对我们的鼓励,在您得到帮助的同时,请您尽可能的去帮助他人.真情互助,携手抗冻,因为我们是一家人!

    该用户从未签到

    发表于 2017-5-13 17:54:53 | 显示全部楼层
    这个药现在在国内能买到吗?

    真情互助,携手抗冻,我们是一家人!
    塑料油论坛LED广告
    帖子凝聚着我们的辛劳,回帖是对我们的鼓励,在您得到帮助的同时,请您尽可能的去帮助他人.真情互助,携手抗冻,因为我们是一家人!
    您需要登录后才可以回帖 登录 | 欢迎注册

    本版积分规则

    关于我们|手机版|小黑屋|运动神经元病互助家园 ( 浙IPC备120211305

    GMT+8, 2019-8-19 14:07 , Processed in 0.156250 second(s), 39 queries , Gzip On.

    Powered by Discuz! X3.4 Licensed © 2001-2013 Comsenz Inc & Style Design

    快速回复 返回顶部 返回列表