FDA Approves Rezzayo, a Novel Echinocandin
The FDA approved rezafungin for injection (Rezzayo, Cidara Therapeutics/Melinta Therapeutics), a novel echinocandin, for the treatment of candidemia and invasive candidiasis in adults 18 years of age or older with limited or no alternative treatment options.
This is the first new FDA-approved echinocandin in more than a decade.
The FDA approval was based on clinical data from Cidara’s global ReSTORE phase 3 trial and supported by the STRIVE phase 2 clinical trial, as well as an extensive nonclinical development program. In clinical studies, rezafungin, dosed once weekly, demonstrated statistical non-inferiority versus caspofungin, a current once-daily standard of care, and met the FDA primary end points.
In addition, overall rates of adverse events and serious adverse events were comparable in patients receiving rezafungin and caspofungin, while rates of adverse events leading to study drug discontinuation were also similar for rezafungin and caspofungin. Based on Qualified Infectious Disease Product designation, rezafungin was approved under Priority Review.
More than 90% of invasive fungal infections begin in the hospital, with infections caused by Candida comprising most of these potentially deadly infections. Current treatments have significant limitations including toxicities, drug–drug interactions, daily IV administration or increasing resistance to treatments. As a once-weekly injection, rezafungin has the potential to simplify the management of candidemia and invasive candidiasis and address unmet medical needs for patients.
Clinical data from Cidara’s global ReSTORE phase 3 trial showed that rezafungin, dosed once weekly, met the FDA and European Medicines Agency primary end points demonstrating statistical non-inferiority versus caspofungin, a current once-daily standard of care. Safety data for rezafungin also were comparable to caspofungin.
The most common adverse reactions are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation and hypophosphatemia. Rezafungin may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea or chest tightness. If these reactions occur, slow or pause the infusion.
Rezafungin may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation.
Abnormalities in liver tests have been seen in clinical trial patients. Monitor those who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing rezafungin therapy.
Rezafungin has not been studied in patients with endocarditis, osteomyelitis and meningitis due to Candida. For the full prescribing information click here.
“The FDA approval of Rezzayo is tremendous news for those of us who have been hoping for a new option to treat our patients with these deadly fungal infections. Based on the totality of clinical data generated, Rezzayo has the potential to simplify the management of invasive candidiasis and enhance the continuity of echinocandin care,” said George Thompson, MD, a principal investigator in the ReSTORE trial and professor of clinical medicine at the University of California, Davis School of Medicine, in Sacramento.
Melinta has exclusive rights to commercialize rezafungin in the United States, and the company anticipates bringing the drug to patients this summer.
Rezafungin is also being studied invasive fungal disease prophylaxis for adults undergoing an allogeneic stem cell transplant.
MARCH 24, 2023
