Cidara, Melinta report FDA advisors recommend approval for rezafungin

Cidara Therapeutics and Melinta Therapeutics announced earlier that the U.S. Food and Drug Administration, FDA, Antimicrobial Drugs Advisory Committee voted favorably 14 to 1 that Cidara, as part of its New Drug Application, NDA, provided sufficient evidence supporting a favorable benefit-risk assessment for a limited use indication for rezafungin for the treatment of candidemia and invasive candidiasis in adult patients with limited or no alternative treatment options. "We are extremely pleased that the FDA’s advisory committee has recommended that the FDA approve rezafungin for difficult-to-treat and often deadly candidemia and invasive candidiasis," said Jeffrey Stein, Ph.D., president and CEO of Cidara. "This positive recommendation is a significant step towards our goal of providing a once-weekly treatment option for patients with invasive Candida infections, for which no new drugs have been approved in over a decade. We believe rezafungin, if approved, could provide an effective new alternative for patients battling these potentially deadly diseases. We want to thank the many patients and healthcare teams who have participated in the clinical studies of these deadly infections, and we look forward to working with the FDA as it completes its review of our application." The Committee’s positive vote was based on clinical data from the Cidara’s global ReSTORE Phase 3 and supported by the STRIVE Phase 2 clinical trials and extensive non-clinical development program. Rezafungin dosed once-weekly demonstrated statistical non-inferiority versus caspofungin, the current standard of care, dosed once-daily, meeting the primary endpoints for both the FDA and the European Medicines Agency.