Cidara Therapeutics and Melinta Therapeutics’ Rezzayo approved by FDA

Cidara Therapeutics and Melinta Therapeutics announced that the FDA approved Rezzayo for injection for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. Rezzayo is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade. In clinical studies, Rezzayo , dosed once-weekly, met the FDA and EMA primary endpoints, demonstrating statistical non-inferiority versus caspofungin, a current once-daily standard of care. In addition, overall rates of adverse events and serious adverse events were comparable in patients receiving Rezzayo and caspofungin, while rates of adverse events leading to study drug discontinuation were also similar for Rezzayo and caspofungin. Last year, Melinta had acquired the exclusive rights to commercialize Rezzayo in the U.S. from Cidara. Cidara retains the rights to rezafungin in Japan and has licensed the commercial rights to Melinta Therapeutics in the U.S. and Mundipharma in all other geographies. The EMA accepted the marketing authorization application for rezafungin in August 2022 and it is currently under review.