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默沙东提交2个抗生素新药上市申请,获FDA优先审评

医药魔方 医药魔方 来源:医药魔方
2019-02-07
新药 默沙东
原文

2月5日,默沙东宣布FDA受理其两项抗生素新药的上市申请,并授予优先审评资格。包括:


1) relebactam联合imipenem/cilastatin (MK-7655A, IMI/REL)治疗疑似革兰阴性菌引起的没有其他替代疗法的成人复杂性尿路感染(cUTI)和复杂性腹腔感染(cIAI)的上市申请,PDUFA预定审批期限是2019年7月16日。


2)Zerbaxa(Ceftolozane/他唑巴坦)治疗成人医院获得性肺炎的补充新药上市申请,PDUFA预定审批期限是2019年6月3日。


IMI/REL (MK-7655A)  的上市申请主要基于关键III期RESTORE-IMI 1研究的结果;Zerbaxa的sNDA主要基于关键III期ASPECT-NP研究的结果。默沙东同时也向EMA提交了上述两项新药申请,目前处于审评中。


Relebactam是静脉注射用的A类(超广谱β内酰胺酶和KPC)和C类(AmpC酶)广谱β内酰胺酶抑制剂,Relebactam联合IMI/REL用于特定革兰阴性菌感染被FDA授予了合格传染病产品(QIDP)资格,以及治疗复杂尿路感染、医院获得性肺炎、呼吸机相关性肺炎的快速通道资格。


Zerbaxa目前已经在美国获批治疗特定革兰阴性菌引起的成人复杂性尿路感染、肾盂肾炎,以及联合甲硝唑治疗特定革兰阴性菌或革兰阳性菌引起的成人复杂性腹腔内感染。


机器翻译

On February 5, Merck announced that FDA has accepted two new antibiotic drug applications and granted priority review.Includes:

1) Relebactam in Combination with Imipenem/Cilastatin (MK-7655A, IMI/REL) for the Treatment of Complicated Urinary Tract Infections (cUTI) and Complicated Intra-abdominal Infections (cIAI) in Adults Suspected to be Caused by Gram-negative Bacteria with a PDUFA Scheduled Approval Period of 16 July 2019.

2) Zerbaxa (Ceftolozane/Tazobactam) Supplemental New Drug Application for the Treatment of Hospital-Acquired Pneumonia in Adults, PDUFA scheduled approval date is June 3, 2019.The marketing application for

IMI/REL (MK-7655A) is primarily based on the results of the pivotal phase 3 RESTORE-IMI 1 study; Zerbaxa's sNDA is primarily based on the results of the pivotal phase 3 ASPECT-NP study.Merck also submitted two new drug applications to EMA, which are currently under review.

Relebactam is a class A (ultra-broad beta-lactamase and KPC) and a class C (AmpC enzyme) broad-spectrum beta-lactamase inhibitor for intravenous injection, and Relebactam in combination with IMI/REL for specific Gram-negative infections by the FDA Qualified infectious disease product (QIDP) qualification, as well as treatment of complex urinary tract infections. Hospital acquired pneumonia. Fast-track qualification for ventilator-associated pneumonia.

Zerbaxa is currently approved in the United States for the treatment of adult complicated urinary tract infections caused by specific Gram-negative bacteria. Pyelonephritis, and combined with metronidazole for the treatment of adult complicated intra-abdominal infections caused by specific Gram-negative or Gram-positive bacteria.

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