Valley Fever Drug Treatment Receives Fast-Track Designation by the FDA Under GAIN Act

Bakersfield, CA - The U.S. Food and Drug Administration (FDA) granted the potential curative anti-Valley Fever drug  nikkomycin Z (NikZ) as a “qualifying infectious disease product”  (QIDP) under the GAIN Act, which will help move it into clinical trials and eventually help patients.

The QIDP designation is a provision of the GAIN Act, approved by Congress in 2012 to help provide incentives to produce new treatments for serious and orphan bacterial and fungal diseases.

Chairman of the Congressional Valley Fever Task Force, Rep. Kevin McCarthy (CA-23) and Co-Chairman, Rep. David Schweikert (AZ-06) successfully requested that Coccidioides species known to cause what is commonly referred to as Valley Fever be added to the list of Qualifying Pathogens under the GAIN Act.

Congressional Valley Fever Task Force Chair Congressman McCarthy issued this statement:

“This is another important step forward in our fight against Valley Fever and I applaud the ongoing work of Dr. Galgiani and his team. He and David Larwood spoke of the potential of NikZ last September at our Valley Fever Symposium.  To see this potential cure moving forward shows how far we have come from working to raise awareness of Valley Fever to making strides to achieving our goal of erasing this disease from our communities.  I look forward to continue our work in collaboration with the FDA, CDC and NIH to combat this disease.”

Congressional Valley Fever Task Force Co-Chair Congressman David Schweikert issued this statement:

“The continued development of the anti-Valley Fever drug Nikkomycin Z (NikZ) is a huge win. It will help all those who struggle with this disease and those fighting against it in the medical community on a daily basis.  I congratulate Dr. John Galgiani and his team at the University of Arizona on their relentless efforts to find a cure. I look forward to continued collaboration with the Valley Fever Task Force and organizations working to find ways to raise awareness of and ultimately beat this disease.”

David Larwood, President and CEO of Valley Fever Solutions, Inc. issued this statement:

"Bakersfield and Kern County have been leaders for decades in supporting efforts to treat and prevent Valley Fever. This QIDP designation builds on important contributions by the CSU Bakersfield Foundation in preserving the Nikkomycin-Z from Shaman Pharmaceuticals for transfer to the University of Arizona. As a Native Son of Kern County, I am proud to build on efforts in our community, and we thank the community for their continuing support."

Background:

In March 2013, the Centers for Disease Control and Prevention released a report detailing a significant increase in Valley Fever incidences between 1998 and 2011 and that calls for additional research into Valley Fever prevention and treatment.  On July 31, 2013, Congressional Valley Fever Task Force Chairman Kevin McCarthy, Co-Chairman David Schweikert, and Task Force members Reps. Ron Barber, Ken Calvert, Michael Conaway, Paul Cook, Jim Costa, Doug LaMalfa, Buck McKeon, David Valadao, and Juan Vargas sent a letter to FDA Commissioner Margaret Hamburg requesting that the fungal pathogens that cause coccidioidomycosis, commonly referred to as Valley Fever, be included on the list of Qualifying Pathogens that FDA was developing as required by Public Law 112-144. 

In June 2014, the FDA added the underlying fungi species responsible for Valley Fever to the list of qualifying pathogens. By including Coccidioides on this list, FDA will give priority and expedited review to Valley Fever treatment and vaccine drug applications, as well as extend for 5 years the marketing exclusivity period for these products. These incentives will help promote the development of drugs to prevent or cure Valley Fever, which is prevalent across the American Southwest.

Dr. John Galgiani, MD, Director of the University of Arizona’s Valley Fever Center for Excellence and David Larwood, President and CEO of Valley Fever Solutions, Inc. both spoke on the potential of NikZ at the Valley Fever Symposium held in Bakersfield, September 23-24, 2013.

###