FDA has granted Qualified Infectious Disease Product and Fast Track designations for the company’s prophylaxis development program for its lead antifungal product candidate, rezafungin for injection.
The drug is sponsored by Cidara Therapeutics Inc.
Specifically, the QIDP designation is for the development of rezafungin for the prevention of invasive fungal infections in adults undergoing allogeneic bone marrow transplantation. Cidara previously announced QIDP designation for rezafungin for the treatment of invasive fungal infections caused by Candida.
Cidara is developing rezafungin, a novel antifungal echinocandin, as a once-weekly, high-exposure therapy for the treatment and prevention of serious invasive fungal infections. Rezafungin is being studied to address unmet needs in the treatment of candidemia and invasive candidiasis as well as for prophylaxis of invasive fungal infections due to common fungal pathogens: Candida, Aspergillus and Pneumocystis.
No agent has been approved to date to prevent infections caused by these pathogens and current prophylaxis regimens often require multiple antifungal drugs with safety and tolerability issues. Cidara plans to commence the phase III ReSPECT prophylaxis clinical trial of rezafungin in patients undergoing allogeneic bone marrow transplantation in the first quarter of 2019.
The QIDP designation, provided under the Generating Antibiotic Incentives Now Act, offers certain incentives for the development of new antifungal and antibacterial drugs, including Fast Track, priority review and, if rezafungin is ultimately approved by the FDA, eligibility for an additional five years of marketing exclusivity. Fast Track designation enables more frequent interactions with the FDA review team to expedite drug development.
