San Diego's Vical Inc. has won a "qualified infectious disease product" designation from the U.S. Food and Drug Administration for a proposed treatment of invasive aspergillosis, a potentially deadly fungal disease.
The infectious disease designation means the product will be eligible for priority review, fast-track treatment through the FDA’s approval process and a five-year extension of exclusivity on the marketplace.
Vical (Nasdaq: VICL) hopes to start Phase 1 preclinical testing on the product within the next nine months.
Vical’s proposed treatment, VL-2397, was initially developed by Japan-based Astellas Pharma Inc., but Astellas granted Vical an exclusive worldwide license to develop and commercialize it in March.
Vical said that in preclinical testing so far, VL-2397 has acted faster against fungi than other treatments currently on the market.
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