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FDA action may speed up valley fever drug development

Oct 6, 2014
In The News

A promising anti-valley fever drug could move into clinical trials more quickly after federal officials declared it a "qualifying infectious disease product," officials announced Friday.

The U.S. Food and Drug Administration gave the designation to nikkomycin Z (NikZ) under the 2012 GAIN Act, which Congress approved to incentivize new treatments for serious and orphan bacterial and fungal diseases, according to Rep. Kevin McCarthy, R-Bakersfield.

"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," McCarthy said in a news release.

As chairman of the Congressional Valley Fever Task Force, McCarthy and the co-chairman, Rep. David Schweikert, R-Ariz., requested the FDA action.

NikZ is a promising fungicide that if gets through clinical trials and is FDA-approved, would be the first medicine specifically formulated to treat and potentially cure valley fever.

The medications valley fever patients take today were developed to treat other illnesses.

Valley fever is an infection of the fungus Coccidioides. The fungus is common in the soil of the western and southwestern United States, including the San Joaquin Valley. Digging and strong wind sometimes sends spores airborne, where they can lodge in the lungs and cause serious illness, including about 200 deaths a year nationally, according to the Centers for Disease Control.

The National Institutes of Health has funded a grant for clinical trials that researchers hope to start in late 2015, said David Larwood, president and CEO of Valley Fever Solutions in Tucson.

But researchers still need patients, FDA approval and drug supply. And drug supply requires investors, who want assurances they'll make money back on the manufacturing of the drug.

That's where designations like the one announced Friday help.

NikZ has been deemed an orphan drug, which will give the drug manufacturer an extra seven years of marketing exclusivity. The designation announced Friday tacks another five years onto that period of exclusivity, Larwood said.

"Somebody has to bite," he said. "The bait just got bigger."