Navigation Links
FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Candidiasis
Date:7/16/2014

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 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.

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 www.astellas.us.

Logo - http://photos.prnewswire.com/prnh/20140416/84970


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... and Company (NYSE: LLY ) today announced that the ... patent would not presently be infringed by Actavis marketing pemetrexed ... Italy and Spain ... --> --> In ... Lilly,s patent would be indirectly infringed by Actavis marketing certain ...
(Date:2/12/2016)... , Feb. 12, 2016  Apellis Pharmaceuticals, ... a $47.1 million Series D preferred stock ... Management, Hillhouse Capital Group and venBio Global ... Investments, AJU IB Investment, and Epidarex Capital. The ... to further advance clinical trials in the ...
(Date:2/11/2016)... 11, 2016 The primary goal of this ... patterns on the usage of liquid biopsy. Key information ... - Timeframe of liquid biopsy adoption amidst future ... Evs—by organization type - Sample inflow to conduct liquid ... stool, serum, and so on. - Correlation analysis of ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... Basketball is a game for everyone, not ... Peety PoppersTM series, sign language translation is featured in the top right of the ... Peety PoppersTM lessons has a sign language translator to teach kids the game and ...
(Date:2/11/2016)... ... February 12, 2016 , ... Fitbody Personal Training offers outdoor training ... exciting way to get fit and healthy. Located in Phoenixville, PA, the classes are ... class designed for horseback riders who want to lose weight and tone up. This ...
(Date:2/11/2016)... (PRWEB) , ... February 11, 2016 , ... ... participated in the American Osteopathic Association’s (AOA) Match Program Tuesday, February 9, taking ... Program places students into osteopathic graduate medical education positions across the country. Of ...
(Date:2/11/2016)... ... February 12, 2016 , ... The Journal of ... from 0.416 in 2013. The SJR uses data taken from the Scopus database (Elsevier ... the number of citations received by the journal over a three year period and ...
(Date:2/11/2016)... ... February 11, 2016 , ... ... diabetes has been gearing up for their simultaneous grand openings in March. All ... right now that you’re probably wondering, is reversing diabetes possible? According to this ...
Breaking Medicine News(10 mins):