FDA Grants QIDP Designation to VT-1129 for Treatment of Cryptococcal Meningitis
Initiation of Phase 1 Program Expected in 4Q 2015
Company to Highlight Potential of VT-1129 at ICAAC/ICC 2015
September 16, 2015, Research Triangle Park, North Carolina – Viamet Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to VT-1129, the company’s novel candidate for the treatment of cryptococcal meningitis. Created under the Generating Antibiotics Incentives Now (GAIN) Act of 2012, QIDP designation provides Viamet with significant incentives for the development of VT-1129, 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.