OCTOBER 8, 2014
Rep. Schweikert GAIN Act inclusion puts promising Valley Fever drug on fast track
The University of Arizona's request to designate the antifungal drug Nikkomycin Z (NikZ) as a qualifying infectious disease product (QIDP) for use in treating Valley Fever has been granted by the U.S. Food and Drug Administration (FDA).
NikZ is a promising, potentially curative anti-Valley Fever drug. Clinical trials will begin in late 2015, years earlier than previously estimated. This is truly a remarkable accomplishment for the entire Arizona community, which has been overwhelmingly affected by Valley Fever.
This was made possible after Co-Chairs of the Congressional Valley Fever Task Force, Congressman David Schweikert (R-AZ) and Majority Leader Kevin McCarthy (R-CA), worked with the FDA to include Coccidioides in the list of qualifying pathogens under the Generating Antibiotic Incentives Now (GAIN) Act of 2012.
Coccidioidosis the fungus that causes Coccidioidomycosis, more commonly known as Valley Fever. Valley Fever is a fungal infection that is contracted through the air and is incredibly prominent in the Southwest region.
Maricopa County alone has 70 percent of all recorded cases of Valley Fever. Thousands more cases go undetected every year. Because of the specific population Valley Fever affects, it is considered an orphan disease. Orphan diseases traditionally lack support from national health intiatives and funding because of the small percentage of the population they affect.
Earlier this year, the FDA recognized Coccidioides in the GAIN Act of 2012. The GAIN Act enables the FDA to delegate resources for use in developing new antibacterial and antifungal drugs for the treatment of serious or life-threatening orphan diseases. The GAIN Act provides incentives such as “fast-track” eligibility and an additional 5 years of market exclusivity.
The designation of the Valley Fever fungus under the GAIN Act was a crucial win for Arizonans. I am thrilled to extend my deepest congratulations to both Dr. John Galgiani, director of the University of Arizona Valley Fever Center for Excellence, as well as the University of Arizona and their partners on this truly remarkable achievement.
