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Ibrexafungerp

(Brexafemme®)

Brexafemme®

Drug updated on 12/11/2024

Dosage FormTablet (oral; 150 mg)
Drug ClassTriterpenoid antifungals
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult and post-menarchal pediatric females for vulvovaginal candidiasis (VVC)
  • Indicated for the treatment of adult and post-menarchal pediatric females for reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).

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Summary
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  • This summary is based on the review of one systematic review/meta-analysis. [1]
  • Ibrexafungerp demonstrated superior clinical cure rates compared to fluconazole/placebo, with a relative risk (RR) of 1.33 [1.07, 1.66], indicating a significantly higher likelihood of clinical cure in patients treated with ibrexafungerp.
  • The mycological eradication rate for ibrexafungerp was also higher than fluconazole/placebo (RR = 1.72 [1.00, 2.95]), reflecting a greater capacity for eliminating the fungal infection.
  • Ibrexafungerp showed an overall success ratio (RR = 1.64 [0.92, 2.92]), demonstrating better outcomes in clinical success when compared to fluconazole/placebo in treating vulvovaginal candidiasis caused by C. albicans.
  • The duration of treatment-emergent adverse events (TEAEs), including nausea and diarrhea, was significantly longer in patients treated with ibrexafungerp compared to those treated with fluconazole/placebo.
  • No serious adverse safety concerns were highlighted in the source, but ibrexafungerp was associated with a higher incidence and longer duration of gastrointestinal-related TEAEs compared to fluconazole/placebo.
  • The population types and subgroup considerations section states that the studies included a total of 880 patients diagnosed with vulvovaginal candidiasis. There is no specific information available on different population types or subgroups (e.g., age, gender, comorbidities) in the reviewed studies, and the findings appear to apply to the general study population.