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FDA批准美金刚胺/多奈哌齐(Namzaric)组合药剂用于治疗阿尔茨海默氏症

2015-01-04 MedSci MedSci原创

美国食品药品监督管理局(FDA)批准固定剂量复方制剂的盐酸美金刚延长释放制剂(XR)和盐酸多奈哌齐(Namzaric,阿特维斯制药 /Adamas Pharm)治疗中度到重度老年痴呆症,患者接受稳定的两种药物剂量。 美金刚XR(Namenda XR, 阿特维斯制药)是一个由N-甲基-D-天门冬氨酸抑制剂,和多奈哌齐(安理申,辉瑞)一种乙酰胆碱酯酶抑制剂(AChEI)。“在一个胶囊里Namzari

美国食品药品监督管理局(FDA)批准固定剂量复方制剂的盐酸美金刚延长释放制剂(XR)和盐酸多奈哌齐(Namzaric,阿特维斯制药 /Adamas Pharm)治疗中度到重度老年痴呆症,患者接受稳定的两种药物剂量。

美金刚XR(Namenda XR, 阿特维斯制药)是一个由N-甲基-D-天门冬氨酸抑制剂,和多奈哌齐(安理申,辉瑞)一种乙酰胆碱酯酶抑制剂(AChEI)。“在一个胶囊里Namzaric组合两个互补疗效的药剂,通常共同规定大约70%使用盐酸美金刚的患者也使用AchEI的治疗”,阿特维斯全球品牌研发部门高级副总裁大卫•尼科尔森,在一次新闻发布会上指出。盐酸美金刚XR和多奈哌齐都证实了其疗效和安全性,用于治疗中度至重度的阿尔茨海默氏症患者。此外,数据显示,盐酸美金刚XR和AchEI的联合疗法对认知上显示了较大的改善,以及全功能的改善相对于单独使用AChEI”,尼克尔森表示。

Namzaric(先前MDX-8704)目前是每日一粒服用的胶囊剂,含有美金刚胺(10毫克每日两次或28毫克XR每日一次)再加上多奈哌齐10毫克。胶囊可以打开,撒在食物上用于有吞咽困难的病人服用。Namzaric可以采用两方面的特点:28/10毫克(美金刚/多奈哌齐)和14/10毫克(美金刚/多奈哌齐)用于有严重肾功能损害的患者。

“在对阿尔茨海默病的中度到重度的阶段病人做治疗决定时,我会考虑治疗的有效性、安全性及其易于管理的特点,”加州科斯塔梅萨ATP临床研究神经精神病学家和医学主任医学博士Gustavo Alva和加州大学志愿者教员欧文在新闻发布会上说。“FDA批准Namzaric提供新的治疗选择,这为病人提供了一个固定剂量组合的药剂,这种药剂在一个胶囊中实现了两种治疗效果”他补充道。

原始出处

Megan Brook. FDA OKs Memantine/Donepezil (Namzaric) Combo Pill for Alzheimer's Disease. December 26, 2014

本文是MedSci原创,转载请注明出处,非常感谢!

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    2015-09-30 bugit
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导读:2014年是礼来最为艰难的一年,数个畅销药遭仿制药重创。而肿瘤学管线中抗癌药Cyramza在今年的表现堪称完美,截至目前已收获FDA 3个批文,并于近日收获欧盟首个批文。业界预测,Cyramza的年销售峰值将突破15亿美元,该药在美欧市场的持续走强,将帮助缓解仿制药冲击导致的销售损失。 礼来(Eli Lilly)近日宣布,欧盟委员会(EC)已批准单抗药物Cyramza(ramuciruma

诺华青光眼药物Travatan(曲伏前列素滴眼液)收获欧盟儿科适应症

眼科护理的全球领导者——诺华旗下眼科单元爱尔康(Alcon)近日宣布,已上市青光眼药物Travatan(曲伏前列素滴眼液,40微克/毫升)收获欧盟儿科适应症。欧盟委员会(EC)已批准Travatan用于青光眼或高眼压症儿科(2月-18岁)患者,降低患者升高的眼内压(IOP)。此前,Travantan的适应症为用于高眼压症或开角型青光眼成人患者降低IOP。 Travatan儿科适应症的获批,意味着

新型药物联合疗法可有效减缓恶性乳腺癌恶化

近日,在2014年圣安东尼奥乳癌研讨会上,来自耶鲁大学的研究人员通过进行一项多中心的II期临床研究表示,一种新型的癌症药物组合疗法或可有效减缓激素受体阳性的转移性乳腺癌患者的病情进展。 研究者表示,试验中招募了118名患转移性激素受体阳性的乳腺癌绝经妇女进行研究,这些研究对象再利用芳香酶抑制剂后癌症并没有得到控制;此前研究结果显示,药物硼替佐米和氟维司群的联合用药相比单独使用氟维司群而言可以

不差钱!辉瑞再砸$3亿支持长效生长激素药物研发!

辉瑞公司在今年似乎是铁了心的抢占各大网站的头条!先是与阿斯利康的相爱相杀让世人惊爆眼球,再是从2014年下半年开始频频出手,投资其他公司的生物医药产品,向业界展示其雄厚的资金。这不,公司最近就宣布公司已经和美国迈阿密的生物医药公司Opko Health达成合作协议,共同开发一种处于临床三期研究的长效生长激素类药物。而为了这一药物,辉瑞公司更是财大气粗的预付了2亿9千5百万美元的预付款。此外,合约中

Lancet:霍奇金淋巴瘤传统治疗方案的优化:减少药物可获更好的疗效?

ABVD方案(doxorubicin, bleomycin, vinblastine, and dacarbazine;阿霉素、博来霉素、长春碱、氮烯唑胺)是目前国际上治疗霍奇金淋巴瘤的一线化疗方案也是目前最有效的方案。但由于博来霉素和氮烯唑胺的药物毒性较大,为了验证这两种药物在ABVD方案中的功能,尤其是在早期良性霍奇金淋巴瘤中起到的作用,来自德国的Karolin Behringer与同事们对A

**反击:FDA授予罗氏眼科药物Lucentis突破性疗法认定

罗氏(Roche)本周收获了一个好消息,FDA已授予眼科药物Lucentis治疗糖尿病性视网膜病变(DR)的突破性疗法认定。此前,FDA于今年9月接受审查Lucentis治疗糖尿病性视网膜病变(DR)的补充生物制品许可(sBLA)并授予优先审查资格。FDA将于2015年2月6日做出最终审查决定。 “突破性疗法”认定,旨在加快某些重症治疗新药的开发和审评。目前,“突破性疗法”新药研发正呈上升势

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