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最近，安斯泰来医药公司迎来了2015年第一个好消息，公司开发的新型抗生素药物isavuconazole顺利通过了FDA下属抗感染药物咨询委员会的审核，为公司向FDA最终提交审核申请扫除了又一个障碍。
此次，抗感染药物咨询委员会专家们审核了其提交的利用isavuconazole治疗曲菌病和毛霉菌病的临床三期研究。最终该委员会以11:0票和8:2票高票通过了安斯泰来的申请。而FDA将于今年的3月8日之前最终做出是否同意其上市的决定。
根据研究人员介绍，曲菌病和毛霉菌病是化疗患者和器官移植患者经常出现的细菌感染疾病，这两种疾病会导致患者出现急性肾衰竭甚至死亡的严重后果。除此之外，公司目前还在进行关于isavuconazole治疗侵袭性念珠菌病的临床三期研究。安斯泰来公司与Basilea Pharmaceutica公司签订了一项协议获得了这种药物。协议规定，安斯泰来公司向Basilea Pharmaceutica支付8600万美元的预付款和5亿5千万美元的里程碑奖金。
这也使得安斯泰来的isavuconazole可能成为2015年首个获批的抗生素药物。
事实上，安斯泰来公司的抗生素研究代表着近年来生物医药产业领域抗生素研究的复兴。自从上世纪初青霉素问世以来，感染问题已经从过去威胁患者死亡的重大问题变为了一种常见小病。然而，由于最初对抗药性的认识并不深入，抗生素滥用问题一直未能得到有效重视。而抗生素的研究利润过低，又使各个生物医药公司对这一领域不闻不问。最终造成了抗药菌越来越难以控制的局面。
而现在，情况已经越演越烈，许多疾病因为超级菌的出现甚至出现了失控的趋势。为了扭转这一局面，美国总统奥巴马的科技顾问委员会（PCAST）建议奥巴马政府采取措施加速新型抗生素的研究，并建议FDA为此类药物的审批设立特殊快速通道，保证其能尽快上市。同时，政府还计划对进行抗生素研究的生物医药企业给予一定的经济鼓励。就在上个月，默沙东公司宣布以95亿美元的价格收购了抗生素研发公司Cubist Pharmaceuticals也被解读为将在这一领域加大投入的信号。
详细英文报道：
A group of independent FDA advisers voted in favor of a new anti-infective fromAstellas Pharma, setting the stage for a likely approval.
The agency's Anti-Infective Drugs Advisory Committee voted that the benefits of Astellas' isavuconazole, to be marketed as Cresemba, outweigh its risks. The injected drug, designed to fight fungal infections, successfully treated invasive aspergillosis and mucormycosis in its two-trial Phase III program, the company said. The two infections are common among patients undergoing chemotherapy or who have received organ transplants, according to Astellas, frequently leading to acute renal failure and death.
The panel voted 11-0 in favor of approving the drug for aspergillosis and split 8-2 with one abstention on whether to recommend it for mucormycosis. The FDA is not required to follow the votes of its advisers, though it commonly does, and the agency is expected to hand down a final decision on isavuconazole by March 8.
Astellas bought into the drug's promise back in 2010, signing a deal with Switzerland's Basilea Pharmaceutica in which it paid $86 million up front and promised about $550 million more if isavuconazole came through on its development and sales goals. Beyond aspergillosis and mucormycosis, the partners are in the midst of Phase III trials against invasive candidiasis, a lethal infection caused by Candida yeasts.
The Japanese drugmaker's embrace of antibiotics follows a trend among the world's largest drugmakers, whose history of inattention to R&D in the field is in part responsible for the current increase in demand--and market opportunity--for anti-infectives. Now, buoyed by government incentives, Big Pharma is creeping back into the space, with Merck ($MRK) trading $9.5 billion for specialist Cubist Pharmaceuticals late last year and well-funded players including of Roche ($RHHBY) and Actavis ($ACT) spending big to beef up their antibiotic pipelines.
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