Published On: Fri, Feb 28th, 2014

Swiss pharma company, Basilea, receives FDA Qualified Infectious Disease Product designation for fungal drug, isavuconazole


Basilea Pharmaceutica Ltd. announced Thursday 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.

Mucor Image/CDC


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.

Ronald Scott, Basilea’s Chief Executive Officer, commented: “The granting of this second QIDP designation for isavuconazole by the FDA is an important regulatory milestone. It further highlights the important potential role of isavuconazole for the treatment of patients with serious or life-threatening invasive fungal infections such as mucormycosis, which is a devastating infection that typically occurs in severely immunocompromised patients such as cancer patients. There are few treatment options for mucormycosis and the infection is associated with high mortality rates if left untreated.”

Isavuconazole is currently in phase 3 clinical development. The results of the two recently completed phase 3 studies (SECURE and VITAL) are planned to form the basis of a potential regulatory filing for the U.S. and Europe mid-2014.



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About the Author

- Writer, Co-Founder and Executive Editor of The Global Dispatch. Robert has been covering news in the areas of health, world news and politics for a variety of online news sources. He is also the Editor-in-Chief of the website, Outbreak News Today and hosts the podcast, Outbreak News Interviews on iTunes, Stitcher and Spotify Robert is politically Independent and a born again Christian Follow @bactiman63


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