安斯泰来（Astellas）2月27日宣布，FDA已授予实验性抗生素isavuconazole合格传染病产品（QIDP）资格认定，用于侵袭性毛霉菌病（nvasive mucormycosis，又名接合菌病）的治疗，该病是由某些新兴霉菌导致的危及生命的侵袭性真菌感染。

这是isavuconazole获得的第2个QIDP认定。此前，FDA已于2013年授予isavuconazole QIDP认定，用于治疗侵袭性曲霉病，该病是由广泛的霉菌所导致的严重真菌感染。

QIDP认定将提供优先审查，以及在美国延长5年的市场独占权。

关于

isavuconazole是一种实验性、每日一次的静脉注射和口服广谱抗真菌药，用于严重侵袭性真菌感染的潜在治疗。相关研究已证明了isavuconazole在体外、体内的广谱抗真菌作用，包括酵母菌（如念珠菌属种）和霉菌（如曲霉属种）。目前，该药已处于III期临床开发阶段。

在美国，FDA已授予isavuconazole快速审批资格，并授予QIDP资格认定和孤儿药地位认定，用于侵袭性曲霉病和毛霉菌病的治疗。

关于

QIDP全称Qualified Infectious Disease Product，是2012年7月美国《FDA安全与创新法案》（FDA Safety and Innovation Act）下GIAN法案（Generating Antibiotic Incentives Now Act）产生的新药特批通道，旨在激励抗生素研发。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（additional five years exclusivity）。

-- If isavuconazole is approved for invasive mucormycosis, QIDP status provides a five-year extension of market exclusivity

NORTHBROOK, Ill., Feb. 27, 2014 /PRNewswire/ -- Astellas Pharma Global Development, Inc., a subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive mucormycosis (also known as zygomycosis), a life-threatening invasive fungal infection caused by certain emerging molds.

QIDP status provides priority review and a five-year extension of market exclusivity in the United States. In 2013, isavuconazole also received QIDP designation for the treatment of invasive aspergillosis, a severe fungal infection caused by widespread molds. These incentives were granted under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as part of the FDA Safety and Innovation Act.

In the event isavuconazole is approved in the United States, the five years QIDP market exclusivity would be in addition to the seven-year exclusivity based on isavuconazole's orphan drug designation for the treatment of zygomycosis that was granted by the FDA in 2013. In the U.S., isavuconazole also has FDA fast-track status and has received orphan drug designation for the treatment of invasive aspergillosis.

"Acceptance of this second QIDP designation for isavuconazole further demonstrates the imp0rtance of developing new agents such as  isavuconazole for patients with serious or life threatening invasive fungal infections such as mucormycosis," said Bernie Zeiher, Senior Vice President and Global Therapeutic Area Head of Immunology and Infectious Diseases at Astellas Pharma Global Development, Inc.

ab0ut Isavuconazole

Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational once-daily intravenous and oral broad-spectrum antifungal for the potential treatment of severe invasive and life-threatening fungal infections. It is currently in phase 3 of clinical development.

Isavuconazole demonstrated in-vitro and in-vivo coverage of a broad range of yeasts (such as Candida species) and molds (such as Aspergillus species) as well as activity in in-vitro studies and in animal models against emerging and often fatal molds including those that cause mucormycosis. In the U.S., isavuconazole was granted FDA fast-track status and received QIDP and orphan drug designation for invasive aspergillosis and mucormycosis (zygomycosis). Isavuconazole is being co-developed with Basilea Pharmaceutica Ltd.

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