-Cresemba capsule injection(isavuconazonium，艾沙康唑注射液，艾沙康唑胶囊)
-美国FDA周五批准了日本安斯泰来的广谱抗真菌药Cresemba(isavuconazonium，艾沙康唑)，该药主要用于治疗侵入性曲霉病和毛霉菌病，这两种真菌感染多发于血癌患者。
侵入性曲霉病是非常罕见的同时又很棘手的真菌病，主要发生于免疫系统紊乱或受到抑制的患者，比如白血病。毛霉菌病也是罕见的病发速度很快的真菌病，发病率及死亡率极高。
Cresemba由安斯泰来与巴塞利亚（Basilea）制药公司共同开发。安斯泰来于去年7月8日在美国提交了Cresemba新药申请。早在今年1月份，Cresemba就以高票通过FDA抗感染药物咨询委员会的评选，详见生物谷报道Astellas新型抗生素药物获得FDA专家委员会高票通过。2月份，获得了该委员会的推荐。FDA曾透露将于3月8日之前公布是否放行的最终决定。果不其然，安斯泰来终于等来好消息！
临床试验数据表明艾沙康唑是安全有效的，与伏立康唑（辉瑞旗下抗真菌药，商品名Vfend）相比，病患死亡率更低。Edward Cox，FDA抗生素药物评价小组带头人，如此评价艾沙康唑“为真菌感染患者提供了另外一个安全有效的治疗方案”
Cresemba也获得了FDA QICP （Qualified Infectious Disease Product）认证，这项认证专门用来鼓励传染病领域的抗生素研发，减少细菌或真菌感染。QICP认证有效期是五年。
安斯泰来美国业务部门领导Jim Robinson表示Cresemba即将上市销售。安斯泰来科学家也正在研究Cresemba对其它真菌感染是否有效，比如侵入性念珠菌病，如果同样有效，受益人群将比上述两种真菌病的人数更多。
|
Drug Name(s) |
CRESEMBA |
|
FDA Application No. |
(NDA) 207500 |
|
Active Ingredient(s) |
ISAVUCONAZONIUM SULFATE |
|
Company |
ASTELLAS |
|
Original Approval or Tentative Approval Date |
March 6, 2015 |
|
Chemical Type |
1 New molecular entity (NME) |
|
Drug Name(s) |
CRESEMBA |
|
FDA Application No. |
(NDA) 207500 |
|
Active Ingredient(s) |
ISAVUCONAZONIUM SULFATE |
|
Company |
ASTELLAS |
Label Information
What information does a label include?10
Note: Not all labels are available in electronic format from FDA.
View the label approved on 03/06/2015 (PDF)11 for CRESEMBA, NDA no. 207500
To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
Approval History
NDA 207500
Note: Not all reviews are available in electronic format from FDA.
Older labels are for historical information only, and should not be used for clinical purposes.
Approval dates can only be verified from 1984 to the present.
Click on a column header to re-sort the table: Download data
|
CRESEMBA |
ISAVUCONAZONIUM SULFATE |
186MG |
CAPSULE;ORAL |
Prescription |
TBD  |
TBD |
|
CRESEMBA |
ISAVUCONAZONIUM SULFATE |
372MG |
INJECTABLE;INJECTION |
Prescription |
TBD |
TBD |
|
Drug Name(s) |
CRESEMBA |
|
FDA Application No. |
(NDA) 207501 |
|
Active Ingredient(s) |
ISAVUCONAZONIUM SULFATE |
|
Company |
ASTELLAS |
Go to Approval History
Label Information
What information does a label include?10
Note: Not all labels are available in electronic format from FDA.
View the label approved on 03/06/2015 (PDF)11 for CRESEMBA, NDA no. 207501
To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
Approval History
NDA 207501
Note: Not all reviews are available in electronic format from FDA.
Older labels are for historical information only, and should not be used for clinical purposes.
Approval dates can only be verified from 1984 to the present.
Click on a column header to re-sort the table: Download data
