Cidara announces REZZAYO approved in EU for treatment of candidiasis in Adults

Cidara Therapeutics announced REZZAYO has been approved in the European Union, EU, for the treatment of invasive candidiasis in adults. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the pivotal ReSTORE Phase III clinical trial, which demonstrated statistical non-inferiority for rezafungin, dosed once weekly, when compared to the current standard of care, caspofungin, dosed once daily. Taylor Sandison, M.D. M.P.H, Chief Medical Officer at Cidara, said, “We welcome the European approval, which makes this treatment option available to patients in Europe alongside patients in the United States following the FDA’s approval earlier this year. This is a great step forward on our journey to help patients with serious Candida infections across the globe.” Rezafungin has been granted Orphan Drug Designation for its use in the treatment of invasive candidiasis in the EU. Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan. Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Union approval of rezafungin in accordance with the terms of the Collaboration and License Agreement, dated September 3, 2019, by and between the Company and Mundipharma.