FDA approves new treatment for candidemia, invasive candidiasis
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Key takeaways:
- Weekly injectable is first new treatment for candidemia and invasive candidiasis in more than a decade.
- Rezzayo expected to be available for use by this summer.
The FDA approved rezafungin for injection to treat candidemia and invasive candidiasis in adults, offering a new treatment for people with limited or no other options.
Approval of the once-weekly, next-generation echinocandin — which will be marketed by Cidara Therapeutics and Melinta Therapeutics as Rezzayo — was based on clinical data from the ReSTORE phase 3 and STRIVE phase 2 trials.
The FDA Antimicrobial Drugs Advisory Committee in January recommended the drug for approval on a 14-1 vote.
According to Cidara, rezafungin for injection is the first new drug treatment for candidemia and invasive candidiasis granted FDA approval in more than a decade.
“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,” Infectious Disease News Editorial Board Member George R. Thompson, MD, professor of clinical medicine at the University of California, Davis School of Medicine and principal investigator in the ReSTORE phase 3 trial of the drug, said in a press release.
“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,” he said.
Data from STRIVE showed rezafungin to be more effective than caspofungin, with 75.8% of participants who received 400 mg of rezafungin weekly and 77.4% who received 400 mg and then 200 mg of rezafungin weekly experiencing clinical cure by day 14 of treatment compared with 71.4% who received caspofungin.
The ReSTORE trial showed rezafungin was as effective as caspofungin, with 55 of 93 patients on rezafungin and 57 of 94 patients on caspofungin experiencing cure by day 14 of treatment.
“In clinical studies, Rezzayo, dosed once weekly, met the FDA and [European Medicines Agency (EMA)] primary endpoints, demonstrating statistical noninferiority versus caspofungin, a current once-daily standard of care,” Cidara said a press release.
“Overall rates of adverse events and serious adverse events were comparable in patients receiving Rezzayo and caspofungin,” the company added.
Melinta Therapeutics, which last year acquired the right to sell Cidara’s Rezzayo in the U.S., said it anticipates the medication will be available sometime this summer. The EMA is currently reviewing an application to sell Rezzayo in Europe.
“The FDA approval of Rezzayo represents a significant milestone for Cidara, and for patients confronted with difficult-to-treat and often deadly candidemia and invasive candidiasis,” Jeffrey Stein, PhD, president and chief executive officer of Cidara, said in the release.
References:
- Cidara Therapeutics. Cidara Therapeutics and Melinta Therapeutics announce FDA approval of Rezzayo (resafungin for injection) for the treatment of candidemia and invasive candidiasis. Published March 22, 2023. Accessed March 23, 2023.
- Cidara Therapeutics. Cidara Therapeutics reports positive topline results from phase 2 STRIVE trial of lead antifungal rezafungin. Published March 19, 2018. Accessed March 23, 2023.
- Thompson GR, et al. Lancet. 2022;doi:10.1016/S0140-6736(22)02324-8.
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