Heidi L Smith, Timothy J Bensman, Shrimant Mishra, Xianbin Li, Cheryl A Dixon, Jalal Sheikh, Owen G McMaster, Abhay Joshi, Daniel B Rubin, Avery Goodwin, Terry J Miller, Zhixia Y Danielsen, Irum Syed, Sunita J Shukla, Dmitri Iarikov, Peter W Kim, John J Farley
On March 22, 2023, the FDA approved rezafungin (REZZAYO) for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options. Rezafungin is an echinocandin that supports weekly dosing, enabling outpatient parenteral treatment that potentially avoids the need for a central venous catheter. Approval of rezafungin was based on a single adequate and well-controlled phase 3 study designed with a Day 30 all-cause mortality primary endpoint and 20% noninferiority margin, which demonstrated that rezafungin is noninferior to the comparator echinocandin...
March 19, 2024: Journal of Infectious Diseases