Navigation Links
FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Candidiasis

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.

About Isavuconazole
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  

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.

About Astellas
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

Logo -

SOURCE Astellas
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Grants Orphan Drug Designation to Omeros OMS721 for Complement-Mediated Thrombotic Microangiopathies
2. FDA Grants Approval of IND to Commence a Phase 3 Pivotal Study for ST10 for the Treatment of Iron Deficiency Anaemia in Chronic Kidney Disease
3. Auxilium Pharmaceuticals, Inc. Announces Court Grants Upsher-Smith Laboratories Motion For Summary Judgment
4. FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Aspergillosis
5. RadSite Grants Accreditation to First Wave of MIPPA Program Applicants
6. NASDAQ Grants China Jo-Jo Drugstores 180-Day Extension to Regain Compliance with Bid Price Requirement
7. U.S. FDA Grants Orphan Drug Designation for KaloBios KB001-A in Treatment of Cystic Fibrosis Patients
8. FDA Grants 510(k) Clearance for Innovative Fuse Gastroscope from EndoChoice
9. Philanthropic Grants, Product Launches, Promising Partnerships, and Customer Satisfaction Rankings - Research Report on CVS Caremark, Walgreens, McKesson, AmerisourceBergen, and Cardinal Health
10. Life Technologies Awards Digital PCR Innovation Grants to Five Research Labs
11. FDA Grants Lillys Ramucirumab Priority Review as a Potential Single-Agent Treatment for Advanced Gastric Cancer
Post Your Comments:
(Date:6/24/2016)... 2016   Bay Area Lyme Foundation , ... Center for Tick Borne Illness , Harvard Medical ... Hacking Medicine, University of California, Berkeley, and the ... five finalists of Lyme Innovation , the ... 100 scientists, clinicians, researchers, entrepreneurs, and investors from ...
(Date:6/24/2016)... ANDOVER, Mass. and SAN CLEMENTE, Calif. ... California -based mobile pulmonary function testing company, is now ... portable PFT devices developed by ndd Medical Technologies , Inc. ... PFT testing done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ... CA , can get any needed testing done in the ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, a ... invasive and more durable cerebrospinal fluid treatments, today ... The Series-A funding is led by Innova Memphis, ... and other private investors.  Arkis, new financing will ... and the market release of its in-licensed Endexo® ...
Breaking Medicine Technology:
(Date:6/25/2016)... , ... June 25, 2016 , ... "With 30 hand-drawn ... specific project," said Christina Austin - CEO of Pixel Film Studios. , ProHand ... all within Final Cut Pro X . Simply select a ProHand generator and ...
(Date:6/25/2016)... ... ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter of ... too high can result in disappointment, perhaps even self-loathing. However, those who set the ... Research from reveals that behind the tendency to set low expectations ...
(Date:6/24/2016)... ... 2016 , ... The Pulmonary Hypertension Association (PHA) learned during ... two significant new grants to support its work to advance research and patient ... recognizing patients, medical professionals and scientists for their work in fighting pulmonary hypertension ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening ... Talker Award, an essay contest in which patients and their families pay tribute to ... at the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this ...
(Date:6/24/2016)... ... ... National recruitment firm Slone Partners is pleased to announce the placement of ... President of North American Capital Sales at HTG Molecular . , ... the commercialization of the HTG EdgeSeq system and associated reagents in North America. , ...
Breaking Medicine News(10 mins):