第一金融网主办
 | 网站首页 | 金融焦点 | 银行 | 股票 | 基金 | 保险 | 期货 | 股评 | 港股 | 美股 | 外汇 | 债券 | 黄金 | 理财 | 信托 | 房产 | 汽车 | 行情 | 
»您现在的位置: 第一金融网 >> 金融焦点 >> 文传商讯 >> 正文

Orphan Drug Designation Granted to Nintedanib for Treatment of Systemic Sclerosis, including Associated Interstitial Lung Disease

2016/9/12 13:14:40  文章来源:文传商讯  作者:文传商讯
文章简介: INGELHEIM,Germany--(BUSINESSWIRE)-- BoehringerIngelheimtodayannouncedthattheEuropeanCommission(EC)andU.S.FoodandDrugAdministration(FDA)

INGELHEIM, Germany -- (BUSINESS WIRE) --

Boehringer Ingelheim today announced that the European Commission (EC) and U.S. Food and Drug Administration (FDA) have granted Orphan Drug Designation to nintedanib for the treatment of systemic sclerosis (SSc, also known as scleroderma), including the associated interstitial lung disease (SSc-ILD).

SENSCIS™, the largest trial to date in this disease area, is specifically evaluating nintedanib to understand the disease process and potential benefit of the compound to treat SSc-ILD.

Systemic sclerosis, commonly referred to as “scleroderma,” is a disfiguring, disabling and potentially fatal rare disease that can cause scarring of the skin, lungs (SSc-ILD) and other organs. Worldwide, an estimated two million people have systemic sclerosis (also known as scleroderma) and up to 90% may develop some degree of lung scarring. SSc-ILD indicates a poor prognosis and accounts for 35 percent of all disease-related deaths.

“Scleroderma and associated interstitial lung disease have a devastating impact on the patient community, and we welcome this important news that a potential new treatment has received Orphan Drug Designation. It’s a crucial step forward in helping to address an unmet need and represents important progress for patients with this rare disease,” said Joep Welling, Federation of European Scleroderma Associations (FESCA aisbl).

Orphan Drug Designation is generally granted by the EC for a therapeutic agent intended to treat a life-threatening or chronically debilitating disease that affects no more than five people in 10,000, and for which there is no or only unsatisfactory treatment options or the medicine will be of significant benefit to those affected by that condition. In the U.S., the FDA grants the status to investigational compounds intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people.

“The Orphan Drug Designation granted by both the European Commission and FDA for nintedanib is an important milestone in the development of much needed therapies for the various complications of systemic sclerosis also known as scleroderma,” said Dr. William Mezzanotte, Therapeutic Area Head, Respiratory Medicine at Boehringer Ingelheim. “The need for treatment options for people with SSc-ILD is significant, and the SENSCIS™ trial is an important first step in exploring the benefit of nintedanib in addressing the complications of systemic sclerosis. The success of nintedanib in treating IPF, in both clinical trials and the clinical world, along with similarities of IPF to other fibrotic lung diseases, including SSc-ILD, gives us great hope that this important medicine can help patients with SSc-ILD. At Boehringer Ingelheim, we are committed to transforming fibrotic lung diseases from fatal diseases to chronic, treatable ones.”

~ ENDS ~

Please click on the link below for ‘Notes to Editors’ and ‘References’:

https://www.boehringer-ingelheim.com/press-release/orphan-drug-designation-granted-nintedanib-treatment-systemic-sclerosis

Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160909005335/en/

 

CONTACT:

Boehringer Ingelheim
Corporate Communications
Media + PR
Anja Heuer (née Konschak)
Phone: +49 6132 – 77 182415
Fax: +49 6132 – 77 6601
Email: press@boehringeringelheim.com

分享到:
第一金融网免责声明:
1、本网站中的文章(包括转贴文章)的版权仅归原作者所有,若作者有版权声明的或文章从其它网站转载而附带有原所有站的版权声明者,其版权归属以附带声明为准。
2、文章来源为均为其它媒体的转载文章,我们会尽可能注明出处,但不排除来源不明的情况。转载是处于提供更多信息以参考使用或学习、交流、科研之目的,不用于 商业用途。转载无意侵犯版权,如转载文章涉及您的权益等问题,请作者速来电话和函告知,我们将尽快处理。来信:fengyueyoubian#sina.com (请将#改为@)。
3、本网站所载文章、数据、网友投稿等内容纯属作者个人观点,仅供投资者参考,并不构成投资建议,与第一金融网站无关。投资者据此操作,风险自担。如对本文内容有疑义,请及时与我们联系。
发表评论

【发表评论】(网友评论内容只代表网友观点,与本站立场无关!)
 姓 名:
 评 分: 1分 2分 3分 4分 5分
 评论内容:
验证码:   *
  • 请遵守《互联网电子公告服务管理规定》及中华人民共和国其他各项有关法律法规。
  • 严禁发表危害国家安全、损害国家利益、破坏民族团结、破坏国家宗教政策、破坏社会稳定、侮辱、诽谤、教唆、淫秽等内容的评论 。
  • 用户需对自己在使用本站服务过程中的行为承担法律责任(直接或间接导致的)。
  • 本站管理员有权保留或删除评论内容。
  • 评论内容只代表网友个人观点,与本网站立场无关。
  • 全站精选
    [新闻]  iphone7发布风光不再 平庸的苹果将如何赚钱?
     最新版吉尼斯世界纪录:最大的嘴、最聪明的猫
    [银行]  收费降低 银行刷卡手续费新规今起施行
     债市反腐风暴席卷中票短融一级半市场 工行恒丰银
    [股票]  多因素叠加致水泥价格“稳涨” 3只龙头股安全边
     下周一机构一致最看好的4金股(9/12)
    [基金]  资本项目可兑换进程再进一步 单家RQFII投资额度
     天天基金周报:沪股通持续净流入 优质蓝筹被看好
    [保险]  社保和商保真正的区别——案例演示
     扩大海外投资 中国人寿16.5亿美元收购曼哈顿标志
    [期货]  期货疯狂 黑色系再现涨停潮
     国际油价难超40美元地板价 国内成品油价短期锁死
    [股评]  机构预测下周大盘走势(9/12)
     下周股市三大猜想及应对策略(9/12)
    [港股]  深港通4个月后“发车” 散户无法买创业板股
     深港通获发“准生证”仿真测试完成 投资创业板初
    [美股]  苹果发布会推出iPhone7和新版手表 相关概念股一
     百度公关团队换帅:前1号店CEO加盟 向李彦宏汇报
    [外汇]  人民币兑美元中间价上调365点 为2005年来最大调
     人民币兑美元中间价贬值196点 降幅逾两月最大
    [债券]  债市反腐风暴延续 消息称多行债券投资经理被抓
     央行今日进行1100亿元7天期逆回购 中标利率2.25
    [黄金]  互金协会禁令:禁止以“创始会员”名义宣传
     黄金热下的黑平台骗局:宣称百分百盈利 诱使客户
    [理财]  调查显示44%女大学生曾遭遇性骚扰 学校不愿公开
     郭德纲曹云金师徒骂战 看武术界如何避免师徒反目
    [信托]  44家信托私募全选择“留下”
     信托上半年盘点:“后7%”时期信托怎么买
    [房产]  30年前假结婚 30年后假离婚
     2016年合肥房产会限购吗
    [汽车]  自由侠1.4T手动挡车型上市,售13.48万
     宾利添越Mulliner版本上市 豪华感提升
  • 此栏目下没有推荐文章
  • | 设为首页 | 加入收藏 | 关于我们 | 友情链接 | 版权申明 | 文章列表 | 网站地图 | 征稿启事 | 广告服务 | 意见反馈 |

    Copyright©2006-2016 afinance.cn All Rights Reserved 版权所有·第一金融网