5 October 2014
FDA Fast Tracks Valley Fever Drug
Posted by John Freeland
Valley fever, a soil-borne disease Terra Central discussed here, is no longer an orphan disease, which means it is no longer too obscure to receive funding for a treatment or a cure.
Last week, the Food and Drug Administration (FDA) granted fast track status to Nikkomycin Z as a “qualifying infectious disease product (QIDP) under the GAIN Act. The GAIN Act was “approved by Congress in 2012 to help provide incentives to produce new treatments for serious and orphan bacterial and fungal diseases” (Scripps Media).
The Congressional Valley Fever Task Force, co-chaired by representative David Schweikert (R-AZ) and Kevin McCarthy (R-CA), worked with the FDA following a 2013 Center for Disease Control report, which found an eight-fold increase in reported Valley Fever cases from 1998 to 2011.
From the CDC report:
Coccidioidomycosis, also known as valley fever, is an infection caused by inhalation of Coccidioides spp. spores. This soil-dwelling fungus is endemic to arid regions of Mexico, Central and South America, and the southwestern United States (1). Symptomatic patients typically experience a self-limited influenza-like illness, but some develop severe or chronic pulmonary disease…
Coccidioidomycosis can be costly and debilitating, with nearly 75% of patients missing work or school because of their illness, and more than 40% requiring hospitalization…
…the incidence of reported coccidioidomycosis increased substantially during this period, from 5.3 per 100,000 population in the endemic area (Arizona, California, Nevada, New Mexico, and Utah) in 1998 to 42.6 per 100,000 in 2011. Health-care providers should be aware of this increasingly common infection when treating persons with influenza-like illness or pneumonia who live in or have traveled to endemic areas.
Clinical trials for Nikkomycin Z are slated to begin next year.