Rezzayo (rezafungin)

To treat candidemia and invasive candidiasis Drug Trials Snapshot

FDA Approval: 3/22/2023

Research Synopsis

  • * It received FDA approval in March 2023, marking a significant development in the management of invasive fungal diseases.
  • * Research highlights rezafungin's strong efficacy compared to existing treatments, maintaining a favorable safety profile and allowing for outpatient administration, thereby reducing complications associated with extended hospital stays.
  • * A recent study demonstrated that rezafungin shows non-inferiority to caspofungin, with similar cure rates and mortality outcomes in treating candidemia and invasive candidiasis.
  • * In vitro studies confirm its effectiveness against fluconazole-resistant strains, making it a viable option in the face of increasing antifungal resistance.
  • * Case studies showcasing rezafungin's efficacy suggest its potential role in treating complex cases like spondylodiscitis, especially when traditional therapies have failed.
  • * Ongoing studies are examining its pharmacokinetics and safety, particularly in patients with liver impairment, indicating a comprehensive understanding of its therapeutic implications.
  • * The emergence of rezafungin is aligned with a broader trend of developing novel antifungals to combat serious infections, reflecting a pressing medical need given the rising mortality rates associated with fungal infections among vulnerable populations.
  • * Future research is critical to establish rezafungin's role in various patient demographics, as well as to explore potential combination therapies and alternative delivery methods to enhance treatment efficacy and patient compliance.

Related articles

Research articles about Rezzayo (rezafungin)

Rezzayo (rezafungin)

Rezafungin: First Approval.

London, UK

2 hours ago

1 Received

  • Rezafungin (Rezzayo™) is a new once-weekly intravenous medication developed by Cidara Therapeutics that targets a specific enzyme to fight fungal infections.
  • In March 2023, it was approved in the USA for treating serious fungal infections like candidaemia and invasive candidiasis in adults who have limited treatment options.
  • The article outlines key developments and milestones that led to this important approval for rezafungin.

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2023 FDA TIDES (Peptides and Oligonucleotides) Harvest.

London, UK

2 hours ago

1 Received

  • In 2023, the FDA approved nine TIDES, including four oligonucleotides targeting disorders like ALS, geographic atrophy, primary hyperoxaluria type 1, and hereditary transthyretin-mediated amyloidosis, all with enhanced stability and effectiveness.
  • The approved peptides exhibit a variety of structures (linear, cyclic, and lipopeptides) and applications, including the first orphan drug designation for a peptide-based chemokine antagonist.
  • Notably, a peptide-based treatment was approved for core symptoms of Rett syndrome, with the analysis of TIDES focusing on their chemical structure, medical targets, and potential side effects.

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Pipeline of Novel Antifungals for Invasive Fungal Disease in Transplant Recipients: A Pediatric Perspective.

London, UK

2 hours ago

1 Received

  • Invasive fungal disease (IFD) presents a serious health risk for children who have undergone transplantation, contributing to high rates of illness and death.
  • The review highlights new antifungal medications that have been recently approved or are in advanced testing stages, focusing on their mechanisms of action, effectiveness, and specific information for pediatric patients.
  • It also examines the important characteristics of these new drugs and their potential future applications in treating pediatric transplant recipients.

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New treatment options for critically important WHO fungal priority pathogens.

London, UK

2 hours ago

1 Received

  • - Fungal infections, often neglected in public health discussions, have a significant global impact, with mortality rates comparable to tuberculosis and HIV, prompting the WHO to identify key fungal pathogens in 2022. - The review highlights ongoing developments in antifungal therapies, focusing on new drugs like ibrexafungerp, oteseconazole, and rezafungin, which have recently gained FDA approval, along with the anticipated approval of olorofim and fosmanogepix. - Despite challenges like limited treatment targets and drug resistance, promising clinical results from these new antifungals could improve outcomes for infections caused by critical fungi.

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An evaluation of Rezafungin: the latest treatment option for adults with candidemia and invasive candidiasis.

London, UK

2 hours ago

1 Received

  • Invasive fungal infections, especially candidemia and invasive candidiasis, pose significant health risks, and the rise of drug-resistant fungal species creates a pressing need for new antifungal treatments.
  • The review discusses in vitro studies on the pharmacokinetics and pharmacodynamics of new antifungal agents, highlighting key clinical studies on their safety and effectiveness.
  • Rezafungin shows strong efficacy compared to other treatments, has a favorable safety profile, and allows for once-weekly dosing, making it a promising option for managing challenging fungal infections in outpatient settings.

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Treatment of native valve endocarditis with rezafungin: a case report.

London, UK

2 hours ago

1 Received

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Salvage Therapy with Rezafungin for Spondylodiscitis: A Case Report from Expanded Access Program.

London, UK

2 hours ago

1 Received

  • Spondylodiscitis is a rare condition with limited treatment options, requiring long-term therapy, typically lasting up to twelve months, and azoles are the only available oral treatment for home therapy.
  • The case study reports a 68-year-old paraplegic patient who experienced reduced efficacy from azole treatment and was successfully treated with 200 mg of rezafungin weekly for 26 weeks after unsatisfactory results with voriconazole and liposomal amphotericin B.
  • Rezafungin demonstrates a promising alternative for treating Candida-related osteomyelitis, especially in cases where standard therapies fail or are poorly tolerated, with the patient showing full recovery without side effects.

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A Mini-Review of In Vitro Data for Species, Including Isolated during Clinical Trials of Three New Antifungals: Fosmanogepix, Ibrexafungerp, and Rezafungin.

London, UK

2 hours ago

1 Received

  • - This mini-review analyzes the clinical outcomes and antifungal susceptibility of three new antifungals: fosmanogepix, ibrexafungerp, and rezafungin, based on isolates from clinical trial patients.
  • - Antifungal susceptibility data primarily comes from the CLSI broth microdilution method or a combination of CLSI and EUCAST methodologies, with specific in vitro results reported for fosmanogepix, ibrexafungerp, and rezafungin.
  • - Overall, the findings provide insights into the effectiveness of these antifungals against various fungal species, although not all clinical isolates have corresponding MIC (minimum inhibitory concentration) data available.

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Outcomes by spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis.

London, UK

2 hours ago

1 Received

  • Rezafungin, a long-acting echinocandin, is effective for treating candidemia and invasive candidiasis, showing non-inferiority to caspofungin in a Phase 3 study.
  • The study included 93 patients on rezafungin and 94 on caspofungin, with similar baseline species distribution across groups and comparable cure rates and mortality outcomes.
  • Efficacy was not affected by minimum inhibitory concentration values, and two patients with non-susceptible isolates had successful outcomes with rezafungin treatment.

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[Innovative therapies for treatment of invasive fungal diseases].

London, UK

2 hours ago

1 Received

  • * New treatment options being developed include novel drugs like Ibrexafungerp and Rezafungin, as well as immunotherapies such as CAR-T cell therapy and monoclonal antibodies for high-risk groups.
  • * Although there have been significant advances in IFD treatment, many emerging therapies are still in clinical trials or preclinical stages, and integrating them into standard clinical practice remains challenging.

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In Vitro Activitiy of Rezafungin in Comparison with Anidulafungin and Caspofungin against Invasive Fungal Isolates (2017 to 2022) in China.

London, UK

2 hours ago

1 Received

  • The study evaluates the effectiveness of rezafungin, a new antifungal, against various invasive fungal isolates and compares it to existing echinocandins, anidulafungin and caspofungin.
  • A total of 1,150 clinical isolates were tested, showing that echinocandins, including rezafungin, maintain strong activity against fluconazole-resistant strains.
  • Sequencing revealed mutations linked to echinocandin resistance, and rezafungin demonstrated comparable efficacy and even higher susceptibility rates, suggesting its potential for clinical use.

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Phase I study of the pharmacokinetics and safety of rezafungin in subjects with moderate/severe hepatic impairment and matched control subjects.

London, UK

2 hours ago

1 Received

  • Rezafungin is a new antifungal drug effective for treating invasive candidiasis, and a study evaluated its pharmacokinetics and safety in patients with moderate to severe liver impairment compared to healthy individuals.
  • The study involved 32 participants, including 8 with moderate and 8 with severe hepatic impairment, who all received a single intravenous dose of rezafungin, with various plasma samples taken to analyze drug concentrations over time.
  • Results showed that drug exposure (AUC) was about 32% lower in both hepatic impairment groups compared to healthy subjects, and while some adverse events occurred, they were not significantly related to the degree of liver impairment.

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Rezafungin (Rezzayo) for invasive Candida infections.

London, UK

2 hours ago

1 Received

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Formulary Drug Review: Rezafungin.

London, UK

2 hours ago

1 Received

  • * Monthly 1-page summary monographs are also provided, which assist with pharmacy/nursing in-services and agendas.
  • * Subscribers can access monographs online, and they can be customized for specific facility needs; for inquiries, contact Wolters Kluwer customer service at 866-397-3433.

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Management of invasive candidiasis: A focus on rezafungin, ibrexafungerp, and fosmanogepix.

London, UK

2 hours ago

1 Received

  • The management of invasive fungal infections is complicated due to rising antifungal resistance, particularly in Candida species, highlighting the need for clinicians to understand multiple factors influencing treatment.
  • This review assesses novel antifungal agents—rezafungin, ibrexafungerp, and fosmanogepix—in treating invasive candidiasis (IC), sharing findings from various studies and databases up to January 2024.
  • Promising data suggests that rezafungin offers a unique advantage with its dosing schedule, ibrexafungerp shows potential for off-label use, and fosmanogepix may become a future treatment option, though more research is essential across different patient demographics.

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Twenty Years in EUCAST Anti-Fungal Susceptibility Testing: Progress & Remaining Challenges.

London, UK

2 hours ago

1 Received

  • The EUCAST Antifungal Susceptibility Testing Subcommittee (AFST) has been refining antifungal susceptibility testing methods for yeast, moulds, and dermatophytes since 2002, including setting epidemiological cut-off values and breakpoints.
  • Key challenges for yeasts like fluconazole resistance and variability in testing methods have been addressed, ensuring reliable clinical recommendations even for rare yeast species.
  • Recent initiatives focus on developing methods to detect antifungal resistance in specific species and creating guidance for molecular testing, while the adoption of EUCAST breakpoints in commercial tests requires careful validation to align with established reference standards.

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[Innovative therapies for treatment of invasive fungal diseases].

London, UK

2 hours ago

1 Received

  • Invasive fungal diseases (IFD) pose a serious risk to immunocompromised individuals and are hard to treat due to issues like antifungal resistance and side effects of current treatments.
  • New treatments are emerging, including orally available drugs like Ibrexafungerp and Rezafungin, along with advanced therapies such as Fosmanogepix and Olorofim, currently in clinical trials.
  • Additionally, immunotherapeutic methods and vaccines are being developed to enhance immune response and prevent infections in high-risk populations, although their clinical effectiveness is still under evaluation.

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In Vivo Efficacy of Rezafungin, Anidulafungin, Caspofungin, and Micafungin against Four Clades in a Neutropenic Mouse Bloodstream Infection Model.

London, UK

2 hours ago

1 Received

  • Rezafungin is a newly approved drug for treating candidaemia and invasive candidiasis, marking a decade-long gap in new treatments, but research on its efficacy is limited.
  • The study involved testing rezafungin and other echinocandins on various fungal isolates in infected mice, focusing on their effects on survival and fungal burdens in different organs.
  • Results showed that rezafungin significantly reduced fungal loads in the kidney and heart, performed comparably or better than other echinocandins, but all treatments failed to effectively target fungal growth in the brain.

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Regulatory Considerations in the Approval of Rezafungin (Rezzayo) for the Treatment of Candidemia and Invasive Candidiasis in Adults.

London, UK

2 hours ago

1 Received

  • On March 22, 2023, the FDA approved rezafungin (Rezzayo) for treating candidemia and invasive candidiasis in adults lacking alternative treatments.
  • Rezafungin is an echinocandin that allows for weekly dosing, potentially reducing the need for central venous catheters by enabling outpatient treatment.
  • The approval was based on a phase 3 study showing rezafungin's effectiveness compared to other echinocandins, with identified safety concerns from animal studies being consistent with the safety profiles of existing approved drugs.

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