2月19日，FDA接收Medicines公司递交的oritavancin上市申请，并授予优先审评资格，PDUFA日期为2014年8月6日。oritavancin是万古霉素类似物，用于治疗革兰阳性菌（包括MRSA）引起的急性细菌性皮肤和皮肤结构感染。该药于2013年12月获得FDA的QIDP资格，可额外叠加5年市场独占权。
Oritavancin是第二代糖肽类抗生素，对革兰氏阳性菌有广谱抗菌效果（包括万古霉素耐药细菌）。该品最初由美国礼来公司研制开发，后美国InterMune公司获得了其在全球范围内的开发和市场权利。早在2002年，美国InterMune公司就期望在次年底递交该产品的新药申请（NDA），然而，却由于一些不良反应的原因而被延迟到2004年底。紧接着，美国FDA又以数据不一致为由要求其提供更多数据。随后，2005年，Targanta公司受让得到了Oritavancin的权利。 2009年1月Medicines公司表示，其已同意以至少4200万美元的价格收购Targanta Therapeutics Corp
在将Oritavancin收入囊中之后，Targanta打算利用3年的时间进行研发，并于2007年底提交该品用于治疗复杂性皮肤和皮肤结构感染的新药申请。然而，其开发进程曾经又因缺乏一个有关生物等效性的Ⅰ期临床研究数据而有所停顿。上述种种因素，均会对该药物在专利保护期内的生命周期持续时间产生影响。
FDA Accepts Filing of The Medicines Company's New Drug Application for Intravenous Antibiotic Oritavancin with Priority Review
PARSIPPANY, NJ -- (Marketwired) -- 02/19/14 -- The Medicines Company (NASDAQ: MDCO) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a new drug application (NDA) for oritavancin, an investigational intravenous antibiotic, with priority review. The Medicines Company is seeking approval of oritavancin for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), administered as a single dose.
In December 2013, the FDA designated oritavancin as a Qualified Infectious Disease Product (QIDP). The QIDP designation provides oritavancin priority review, and an additional five years of exclusivity upon approval of the product for the treatment of ABSSSI. Priority review means the FDA's goal is to take action on the application within six months, compared to 10 months under standard review. The FDA action date (PDUFA date) for oritavancin is August 6, 2014.
"We look forward to working with the FDA during the review process, and sharing the knowledge we have gained in our studies of oritavancin," said Matthew Wikler , MD, Vice President and Medical Director, Infectious Disease Care for The Medicines Company. "We believe that upon approval, oritavancin, administered as a single dose for the treatment of ABSSSI, will offer new options for both physicians and their patients for the treatment of these infections."
The oritavancin NDA is based on data from two Phase 3 clinical trials, SOLO I and SOLO II, which were conducted under a Special Protocol Assessment (SPA) agreement with the FDA. These Phase 3 trials evaluated the efficacy and safety of a single 1200mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with ABSSSI, including infections caused by MRSA. The combined SOLO studies were conducted in 1,959 patients (modified intent-to -treat population, or mITT), with 405 of the patients suffering from an ABSSSI with a documented MRSA infection.
About Oritavancin
Oritavancin is an investigational intravenous antibiotic for which The Medicines Company is seeking approval in the treatment of ABSSSI caused by susceptible gram-positive bacteria, including MRSA. In clinical trials, the most frequently reported adverse events associated with oritavancin were nausea, headache, vomiting and diarrhea. Hypersensitivity reactions have been reported with the use of antibacterial agents including oritavancin.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on 3,000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacificregions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Forward-looking Statements
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "plans," "anticipates" and "expects" and similar expressions, including the Company's preliminary revenue results, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed onNovember 5, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
关键词： FDA Medicines公司 糖肽类抗菌药物 oritavancin 上市
免责声明：
本文仅供专业人士学术交流探讨，不作为诊疗及用药依据。
如有侵权，请联系我们删除