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Once-weekly REZZAYO® met its efficacy outcome of global response at day 141,2
In the pivotal phase III ReSTORE trial, once-weekly REZZAYO® demonstrated non-inferiority in global response at day 14 compared to the once-daily caspofungin group in the mITT population1*
DRC = Data Review Committee
Adapted from REZZAYO® (rezafungin) Summary of Product Characteristics. Napp 20241 and Thompson GR III, et al. 2023.2
Rezafungin was considered non-inferior to caspofungin for global response if the lower bound of the CI was above –20%.
*Stable patients in the caspofungin group who met relevant criteria could step down to fluconazole after 3 days or more.
Secondary efficacy outcomes at the day 14 visit1,2
Adapted from Thompson GR III, et al. 2023.2
This study was not powered to infer similarity between these groups.
*Data Review Committee-assessed global response consisted of clinical cure as assessed by the investigator, radiological cure (for patients with invasive candidiasis documented by radiological or imaging evidence at baseline), and mycological eradication. mITT population includes all subjects who had documented Candida infection based on Central Laboratory evaluation of a culture from blood or another normally sterile site obtained ≤4 days (96 hours) before randomisation and received ≥1 dose of study drug.
Learn more about the ReSTORE study design and secondary endpoints in this clinical trial summary
REZZAYO® secondary efficacy outcome: all-cause mortality at day 301,2
In ReSTORE, all-cause mortality at day 30 in the mITT population1*
Adapted from REZZAYO® (rezafungin). Summary of Product Characteristics. Napp 20241 and Thompson GR III, et al. 2023.2
*Stable patients in the caspofungin group who met relevant criteria could step down to fluconazole after 3 days or more.
Learn more about REZZAYO® from the experts
REZZAYO® was generally well tolerated in the pivotal trial2
Please refer to Section 4.8 of the REZZAYO(R) SmPC for more information on adverse reactions.2
Adapted from Section 4.8 of the REZZAYO® SmPC.
In the phase III trial, ReSTORE, REZZAYO® was generally well tolerated1*
TEAEs and SAEs
Adapted from Thompson GR III, et al. 2023.2
TEAE breakdown
Adapted from Thompson GR III, et al. 2023.2
Please read the REZZAYO® summary of product characteristics in full before prescribing.
Safety population included all subjects who had received ≥1 dose of study drug.
*Stable patients in the caspofungin group who met relevant criteria could step down to fluconazole after 3 days or more.
Learn more about REZZAYO® dosing and pharmacokinetics
CI, confidence interval; DRC, Data Review Committee; EMA, European Medicines Agency; FDA, Food and Drug Administration; mITT, modified intent-to-treat; TEAE, treatment-emergent adverse event.
- REZZAYO® (rezafungin). Summary of Product Characteristics. Napp 2024
- Thompson GR III, et al. Lancet. 2023;401(10370):49–59.
Adverse events should be reported. Reporting forms and information can be found at http://yellowcard.mhra.gov.uk/.
Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444 or drugsafetyUKandROI@mundipharma.com.
®: REZZAYO is a Registered Trademark of Cidara Therapeutics, Inc., used under license