Viamet Pharmaceuticals announced on Thursday that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to VT-1598, a novel candidate for the oral treatment of coccidioidomycosis, or Valley Fever.
Valley Fever is an invasive fungal infection found primarily in the southwest United States that affects an estimated 150,000 people annually.
Created under the Generating Antibiotics Incentives Now (GAIN) Act of 2012, QIDP designation provides significant incentives for the development of innovative antimicrobial agents like VT-1598, including the potential for priority review by the FDA, eligibility for Fast Track status, and a five-year extension of marketing exclusivity under the Hatch-Waxman Act. Previously, the FDA granted orphan drug designation to VT-1598 for the treatment of Valley Fever.
“The FDA’s decision to grant QIDP designation to VT-1598 underscores the significant need for new, effective and safe therapies to treat Valley Fever. The fungus that causes Valley Fever lives in the soil and simply breathing the spores of this pathogen can lead to serious infections of the lung, brain and other internal organs. Anyone living in, or traveling to, the southwest United States is at risk of contracting this serious infection for which current treatment options are very limited,” stated Robert Schotzinger, M.D., Ph.D., and CEO of Viamet.