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【drug-news】抗艾药阿比特龙的新药申请已被提交
Marketing application also submitted to European Health Authorities
HORSHAM, Pa., December 20, 2010 – Centocor Ortho Biotech Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic advanced prostate cancer in patients who have received prior chemotherapy containing a taxane. Janssen-Cilag International NV also filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for abiraterone acetate.
Abiraterone acetate was developed by Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.
Abiraterone acetate is an investigational oral androgen biosynthesis inhibitor being developed for the treatment of metastatic advanced prostate cancer that has developed resistance to conventional hormonal therapies. This is also known as castration-resistant prostate cancer (CRPC). It is believed that abiraterone acetate inhibits a key enzyme, CYP17, needed for androgen biosynthesis in the testes, adrenals and tumor.
Both applications follow completion of a Phase 3, randomized, double-blind, placebo-controlled clinical study (COU-AA-301), which evaluated overall survival and tolerability in patients with metastatic advanced prostate cancer treated with abiraterone acetate plus prednisone compared to treatment with placebo plus prednisone. In September 2010, the company announced that the study was unblinded on the recommendation of an Independent Data Monitoring Committee.
Data from this 1,195 patient study conducted in 147 centers in 13 countries were presented at the 35th Annual European Society for Medical Oncology (ESMO) Congress in October 2010. Additional ongoing studies are currently underway for abiraterone acetate.
“These regulatory file submissions are an important milestone for men with metastatic advanced prostate cancer and for our company,” said William N. Hait, M.D., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Pharmaceutical Research & Development, LLC. “We believe that we can develop important therapies to treat devastating diseases by focusing on the tumor microenvironment. Abiraterone acetate is a key part of this strategy, and we look forward to working with health authorities to provide a new therapeutic option for metastatic advanced prostate cancer patients.”
If approved, abiraterone acetate will be commercialized and distributed by Centocor Ortho Biotech Inc. in the U.S. and by Janssen Pharmaceutical Companies in all other countries around the world.
http://www.centocororthobiotech.com 初译：
Centocor Ortho Biotech Inc. Announces NDA Submission for Abiraterone Acetate for the Treatment of Metastic Advanced Prostate Cancer
Centocor Ortho生物科技公司宣布有关醋酸阿比特龙用于治疗转移性晚期前列腺癌的新药申请已被提交
Marketing application also submitted to European Health Authorities
同时该药的上市申请也已被提交至欧洲健康管理机构
HORSHAM, Pa., December 20, 2010 – Centocor Ortho Biotech Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic advanced prostate cancer in patients who have received prior chemotherapy containing a taxane. Janssen-Cilag International NV also filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for abiraterone acetate.
2010年12月20日，美国宾夕法尼亚州HORSHAM消息——Centocor Ortho生物科技公司已向美国食品药品监督管理局（FDA）提交了一项有关研究性药物醋酸阿比特龙（abiraterone acetate）联用泼尼松以治疗之前已接受过含紫杉碱（taxane）化疗的转移性晚期乳腺癌患者的新药申请（NDA）。同时，Janssen-Cilag International NV公司也已向欧洲药管局（EMA）提交了一项有关醋酸阿比特龙的上市批准申请（MAA）。
Abiraterone acetate was developed by Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.
醋酸阿比特龙由Cougar生物科技公司下属的Ortho生物科技肿瘤产品研发公司负责研发。
Abiraterone acetate is an investigational oral androgen biosynthesis inhibitor being developed for the treatment of metastatic advanced prostate cancer that has developed resistance to conventional hormonal therapies. This is also known as castration-resistant prostate cancer (CRPC). It is believed that abiraterone acetate inhibits a key enzyme, CYP17, needed for androgen biosynthesis in the testes, adrenals and tumor.
醋酸阿比特龙是一种研究用口服雄激素生物合成抑制剂，用于治疗已发生对传统激素治疗耐药的转移性晚期前列腺癌，后者又名去势治疗失败的前列腺癌（CRPC）。据称，该药可抑制在睾丸、肾上腺和肿瘤中的雄激素生物合成所需的关键酶（CYP17）。
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作者:admin@医学,生命科学 2011-01-12 00:06
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