FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Candidiasis
If isavuconazole is approved for invasive candidiasis, QIDP status provides a five-year extension of market exclusivity.
NORTHBROOK, Ill., July 16, 2014 /PRNewswire/ -- Astellas today announced that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive candidiasis, a life-threatening, invasive fungal infection.
A product that is granted QIDP status receives a priority review and a five-year extension of market exclusivity in the United States. Previously, isavuconazole received QIDP designation for invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). The incentives for all three conditions were granted under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as a part of the FDA Safety and Innovation Act.
"The need to treat serious fungal infections can be one of life or death. This QIDP designation, along with the previous two we have received, emphasizes how important it is to patients and their families that products are available to treat these infections," said Bernie Zeiher, Executive Vice President, Global Development and Therapeutic Area Head of Infectious Disease at Astellas.
Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational once-daily intravenous and oral broad-spectrum antifungal being developed for the treatment of severe invasive and life-threatening fungal infections. Isavuconazole is the active moiety of the prodrug isavuconazonium sulfate. Information regarding isavuconazole ongoing clinical trials is available at clinicaltrials.gov.
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 against emerging and often fatal molds including those that cause mucormycosis.
In the Phase 3 invasive aspergillosis study, isavuconazole demonstrated non-inferiority to voriconazole on the primary endpoint of all-cause mortality at day 42. The treatment-emergent adverse events for isavuconazole were statistically fewer relative to voriconazole in the System Organ Classes of hepatobiliary, skin and eye disorders. In both treatment groups, the most common treatment emergent adverse events were nausea, vomiting, pyrexia (fever) and diarrhea.
Isavuconazole is being co-developed with Basilea Pharmaceutica International Ltd.
About Astellas Infectious Disease
Astellas' commitment to the field of infectious diseases is an active one. We're expanding the knowledge base of this therapeutic area and empowering physicians to make evidence-based clinical decisions.
Our proud history of collaborating with investigators around the world provides ideal environments to study compounds that have the potential for significant breakthroughs and allows us to generate and publish key information on our advances. In fact, Astellas has performed some of the world's largest clinical trials in fungal infections.
Astellas is a pharmaceutical company dedicated to improving the health of people around the world through provision of innovative and reliable pharmaceuticals. The headquarters for the Americas is located in Northbrook, Ill. For more information on Astellas, please visit our website at www.astellas.us.
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For further information: Marjorie Moeling, Marjorie.Moeling@Astellas.com, 224-205-5205