First Topical Echinocandin Antifungal Granted QIDP, Fast Track Designation
Cidara announced that the Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) status to its CD101 topical, for the proposed treatment for vulvovaginal candidiasis (VVC) and prevention of recurrent VVC (RVVC).
CD101 represents the first echinocandin antifungal to be developed as a topical treatment with a broad spectrum of activity against the Candida species. The QIDP label qualifies CD101 as Fast Track designation, enables priority review and, if ultimately approved, it will have 5 years of marketing exclusivity.
RADIANT, a Phase 2 comparative trial of CD101, is planned to commence in mid-2016. A prerequisite for QIDP designation asserts that the proposed candidate should potentially treat serious or life-threatening infections.
In April, the FDA advised caution when prescribing oral fluconazole for yeast infections after a meta-study found a correlation between increased risk of miscarriage and oral treatment. The Centers for Disease Control and Prevention (CDC) also reported that certain Candida species are becoming increasingly resistant to existing antifungal medications. Currently, the CDC recommends only using topical antifungals to treat pregnant women with vulvovaginal yeast infections.
Earlier this year, the FDA granted Orphan Drug designation to Cidara's CD101 IV, a long-acting echinocandin antifungal. It is being developed as a once-weekly high exposure therapy for the prevention and treatment of serious, invasive fungal infections.
For more information call (858) 752-6170 or visit Cidara.com.