新抗生素Orbactiv（奥利万星）获FDA批准
来源：生物谷 2014-08-07 15:31
2014年8月7日讯 /生物谷BIOON/ --Medicines公司8月6日宣布，FDA已批准抗生素Orbactiv（oritavancin，奥利万星，IV）注射液，用于由敏感革兰氏阳性菌（包括耐甲氧西林金黄色葡萄球菌，MRSA）导致的急性细菌性皮肤和皮肤结构感染（ABSSSIs）成人患者的治疗。Orbactiv是FDA批准用于ABSSSIs治疗的首个和唯一一种单剂量治疗方案的抗生素。患者仅接受一次Orbactiv输液，整个治疗方案便已结束。此次Orbactiv的获批，也代表着细菌性皮肤和皮肤结构感染疾病治疗方面远超当前临床标准的重大进步。目前，患者往往需要多次静脉输注抗生素，而Orbactiv单剂量治疗方案，将显著减少患者的剂量负担。
（另附生物谷文章：《NEJM：单一剂量的抗生素奥利万星（Orbactiv）可有效治疗患者的皮肤组织感染》）
Orbactiv的获批，是基于SOLO I和SOLO II研究的数据，这2项研究均为随机、双盲、多中心临床试验，评估了单剂量Orbactiv（1200mg，静脉注射，IV）治疗方案用于1987例ABSSSI患者的治疗，并对记录有MRSA感染的一个大亚组患者（n=405）进行了评估。这些实验证明，仅注射一次Orbactiv（1200mg，IV）与7-10天每天注射2次万古霉素（1g或15mg/kg体重）在主要终点和次要终点均具有非劣性（non-inferiority）。
此前，FDA已授予Orbactiv合格传染病产品（QIDP）资格。QIDP是2012年7月美国《FDA安全与创新法案》（FDA Safety and Innovation Act）下GIAN法案产生的新药特批通道，旨在激励抗生素研发，以应对严重威胁生命的细菌感染。简单地说，QIDP=研究阶段快速通道（fast track）+审批阶段优先审评（priority review）+上市后5年额外市场独占权。
目前，欧洲药品管理局（EMA）正在审查Orbactiv的上市许可申请（MAA），该申请中，Medicines公司寻求批准用于复发皮肤和软组织感染（cSSTI）的治疗。欧盟委员会（EC）预计将于2015年上半年做出最终审查决定。
此次FDA批准Orbactiv，也代表着该公司管线中首个用于耐药菌感染性疾病治疗药物。该公司正在开发横跨革兰氏阳性菌（包括MRSA）和革兰氏阴性菌导致的广泛感染性疾病的解决方案，其新兴的管线产品有望提供创新的抗生素，具有解决当前许多传染病的潜力。
Orbactiv注射液适用于如下革兰氏阳性菌敏感株导致的急性细菌性皮肤和皮肤结构感染（ABSSSIs）成人患者的治疗，包括：金黄色葡萄球菌（包括甲氧西林敏感和甲氧西林耐药菌株）、化脓性链球菌、无乳链球菌、停乳链球菌、咽峡炎链球菌群（包括S. anginosus、S. intermedius和S. constellatus）和粪肠球菌（仅万古霉素敏感株）。（生物谷Bioon.com）
英文原文：FDA Approves The Medicines Company's ORBACTIV™ (oritavancin) for Use in Acute Bacterial Skin and Skin Structure Infections
First and Only Single Dose Antibiotic for the Treatment of Skin Infections Caused by Susceptible Designated Gram-positive Bacteria
ORBACTIV™U.S. Launch Expected in 2H/2014
PARSIPPANY, N.J.--(BUSINESS WIRE)--The Medicines Company (NASDAQ:MDCO) today announced that the U.S. Food and Drug Administration (FDA) has approved ORBACTIV™ (oritavancin) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). ORBACTIV is the first and only antibiotic approved by FDA to treat ABSSSIs with a single, once-only administration. Once fully infused over three hours, the ORBACTIV treatment regimen is complete for patients with skin infections caused by susceptible Gram-positive pathogens.
“Today’s FDA approval of ORBACTIV represents an important advance beyond the current standard of care for bacterial skin and skin structure infections,” said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company. “This approval is also a significant milestone for The Medicines Company as we continue to develop our infectious disease care portfolio. We are committed to addressing the complex problems associated with multi-drug resistant infections.”
ORBACTIV approval is based on the results of the SOLO I and SOLO II clinical studies which were randomized, double-blind, multicenter trials that evaluated a single 1200 mg IV dose of ORBACTIV for the treatment of ABSSSI in 1,987 patients, and assessed a large subset of patients with documented MRSA infection (405 patients). These trials demonstrated non-inferiority for the primary and secondary endpoints evaluating 1200 mg once-only IV ORBACTIV dose infusion, versus 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg).
“ORBACTIV given as a single dose treatment is a welcome new development for the treatment of skin infections,” said G. Ralph Corey, MD, Professor of Medicine and Infectious Diseases at Duke University. “With a single dose treatment regimen ORBACTIV may help reduce the dosing burden seen with antibiotics given as multiple intravenous administrations to patients with these infections.”
“The growing challenge of antibiotic resistance in the U.S. has had a significant impact on the clinical management decisions in the emergency department,” said Charles Pollack, MD, Chair, Department of Emergency Medicine, Pennsylvania Hospital and Professor of Emergency Medicine at the Perelman School of Medicine at the University of Pennsylvania. “A single, once-only IV therapy such as ORBACTIV offers the option to administer a single treatment in the outpatient setting for patients with skin infections caused by Gram-positive bacteria likely due to MRSA.”
ORBACTIV was designated as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies ORBACTIV for certain incentives related to the development of new antibiotics, including a five-year extension of any non-patent exclusivity period awarded to the drug.
The European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) for ORBACTIV, for which the company is seeking approval for the treatment of complicated skin and soft tissue infections (cSSTI). A decision from the European Commission is expected during the first half of 2015.
The FDA approval of ORBACTIV represents the first infectious disease treatment in The Medicines Company’s product pipeline to address infections caused by resistant strains of bacteria. The Medicines Company is developing solutions that span the spectrum of infections caused by Gram-positive bacteria including MRSA, and Gram-negative infections. The Medicines Company’s emerging product pipeline has the potential to offer innovative new antibiotic approaches to tackle many of the problems in infectious diseases today.
About ORBACTIV
Indication
ORBACTIV™ (Oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:
Staphylococcus aureus (including methicillin-susceptible and methicillin–resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only). |
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