FDA Grants Astellas Qualified Infectious Disease Product Designation For Isavuconazole For The Treatment Of Invasive Mucormycosis
Published: Feb 27, 2014
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 importance 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.
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.
Astellas Pharma Global Development, Inc., located in Northbrook, Illinois, is a member of the Astellas group of companies. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. For more information about Astellas Pharma Inc., please visit our website at www.astellas.com/en.
SOURCE Astellas Pharma Global Development, Inc.
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