FDA committee recommends approval of rezafungin for candidemia and invasive candidiasis
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The FDA Antimicrobial Drugs Advisory Committee voted on Wednesday 14-1 in favor of the use of rezafungin for the treatment of candidemia and invasive candidiasis.
“We are extremely pleased that the FDA’s advisory committee has recommended that the FDA approve rezafungin for difficult-to-treat and often deadly candidemia and invasive candidiasis,” Cidara President and CEO Jeffrey Stein, PhD, said in a statement.
“This positive recommendation is a significant step toward our goal of providing a once-weekly treatment option for patients with invasive Candida infections, for which no new drugs have been approved in over a decade,” Stein said.
The vote was based on positive clinical data from the global ReSTORE trial, a phase 3 trial comparing the safety and efficacy of rezafungin vs. caspofungin and STRIVE, a phase 2 trial evaluating safety, tolerability and efficacy of rezafungin.
The ReSTORE trial was performed using 199 adults from 15 countries between Oct. 12, 2018, and Aug 29, 2021. Researchers randomly assigned 100 participants to the rezafungin group and 99 to the caspofungin group.
According to the study, 55 of 93 patients in the rezafungin group and 57 of 94 patients in the caspofungin group had a global cure at day 14, whereas 22 of 93 patients in the rezafungin group and 20 of 94 patients in the caspofungin group died or had an unknown survival status at day 30.
The safety analysis showed that 89 of 98 patients in the rezafungin group and 83 of 98 patients in the caspofungin group had at least one treatment-emergent adverse event, with the most common being pyrexia, hypokalemia, pneumonia, septic shock and anemia.
Healio previously reported that data from STRIVE showed that 75.8% of patients who received 400 mg of rezafungin weekly; 77.4% who received 400 mg, then 200 mg of rezafungin weekly; and 71.4% who received caspofungin daily had a clinical cure by day 14.
Overall mortality rates were 15.2% in the 400 mg rezafungin arm, 9.7% in the 400 mg/200 mg rezafungin arm and 17.9% in the comparator arm.
The safety analysis also showed that 88.6% in the 400 mg rezafungin arm, 94.4% in the 400 mg/200 mg rezafungin arm and 81.8% in the comparator arm reported treatment-emergent adverse events, although the researchers reported that “no concerning trends in adverse events” were observed.
Cidara said that both studies met the primary endpoints for both the FDA and the European Medicines Agency.
If approved by the FDA, rezafungin will be the first new drug for the treatment of candidemia and invasive candidiasis in more than a decade, according to a company press release. The agency has assigned a PDUFA target action date of March 22, 2023, enabled by rezafungin’s designation as a Qualified Infectious Disease Product.
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