FDA Grants Valley Fever Antifungal QIDP Designation
Created under the Generating Antibiotics Incentives Now (GAIN) Act of 2012, QIDP designation provides significant incentives for the development of innovative antimicrobial agents.
Officials with the US Food and Drug Administration (FDA) have granted Qualified Infectious Disease Product (QIDP) designation to an oral treatment for coccidioidomycosis. The designation follows an earlier orphan drug designation to the antimicrobial known as VT-1598 (Viamet).
VT-1598 is being developed to treat valley fever, a systemic fungal infection in the southwestern United States. According to a press release from Viamet, in preclinical models, VT-1598 was highly effective in treating disease localized to the central nervous system, a common site of dissemination in humans.1
The Infectious Diseases Society of America (IDSA) recently updated guidelines for the management of coccidioidomycosis (valley fever), including treatment recommendations for the first time in more than 10 years.2
The new IDSA guidelines continue to recommend oral azole antifungal agents, usually fluconazole, as the preferred treatment for most manifestations of coccidioidomycosis that require treatment, including infection in the second and third trimesters of pregnancy. Amphotericin remains recommended in the first trimester. High-dose azoles, certain newer azoles, or amphotericin are recommended treatment options when first-line therapy fails.
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 5-year extension of marketing exclusivity under the Hatch-Waxman Act.
- Viamet to Present at the 2016 Mycoses Study Group Education and Research Consortium (MSGERC) Conference [press release]. Research Triangle Park, North Carolina. Viamet. September 19, 2016.
- Galgiani JN, Ampel NM, Blair JE, et al. Executive summary: 2016 Infectious Diseases Society of America (IDSA) clinical practice guideline for the treatment of coccidioidomycosis. Clin Infect Dis. 2016;63(6):717-722. doi: 10.1093/cid/ciw538.