Officials with Vical Incorporated have announced that the Food and Drug Administration has granted a qualified infectious disease product (QIDP) designation to their investigational antifungal product candidate, VL-2397. The QIDP designation is for the treatment of invasive aspergillosis.
The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act of 2012. It provides certain incentives for the development of new anti-infectives, including eligibility for priority review, the FDA’s Fast Track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.
VL-2397, also known as ASP2397, is part of a potential new class of antifungal compounds for the treatment of systemic fungal infections.
Systemic fungal infections are major causes of morbidity and mortality in immunocompromised patients, such as transplant recipients, in patients undergoing chemotherapy and in patients in the ICU.
VL-2397 was initially developed by Astellas Pharma Inc. (TOKYO: 4503). In March 2015, Astellas granted Vical an exclusive worldwide license to develop and commercialize VL-2397.